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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE


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505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01889173 ↗ Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults Completed Tonix Pharmaceuticals, Inc. Phase 1 2013-06-01 Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004284 ↗ Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1995-04-01 OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗ Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria Completed University of Texas Phase 3 1995-04-01 OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗ Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria Completed National Center for Research Resources (NCRR) Phase 3 1995-04-01 OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00120731 ↗ Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones Withdrawn Children's Mercy Hospital Kansas City N/A 2005-07-01 High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years: - children who are hypercalciuric stone formers; - healthy children without a history of hypercalciuria or kidney stones. Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction. The researchers will try to learn whether it is the child's characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better "tailor" the individual treatment for each child with kidney stones.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention Trials
Healthy 3
Kidney Stones 2
Hyperkalemia 2
Respiratory Distress Syndrome, Adult 2
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Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention Trials
Nephrolithiasis 6
Kidney Calculi 6
Hypercalciuria 3
Calculi 3
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Clinical Trial Locations for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location Trials
United States 29
India 3
Canada 3
Switzerland 3
Egypt 3
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Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location Trials
California 3
Minnesota 3
Maryland 3
Illinois 2
Texas 2
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Clinical Trial Progress for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase Trials
Phase 4 11
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase Trials
Completed 23
Not yet recruiting 7
Terminated 5
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Clinical Trial Sponsors for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor Trials
University of Minnesota 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
Rigshospitalet, Denmark 2
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Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor Trials
Other 64
Industry 9
NIH 8
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Clinical Trials, Market Analysis, and Projections for Parenteral Nutrition Solutions: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Introduction

Parenteral nutrition solutions, which include a combination of amino acids, electrolytes, and other nutrients, are crucial for patients who cannot receive nutrition through the gastrointestinal tract. This article focuses on the clinical trials, market analysis, and projections for a specific formulation containing amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride.

Clinical Trials and Safety

Current Status

Clinical trials for parenteral nutrition solutions, particularly those involving amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride, often rely on existing safety data and clinical experience. For instance, the FDA approval for potassium phosphates injection, which is part of this formulation, was based on extrapolation from adult data and extensive clinical experience with similar formulations, such as sodium phosphates and potassium chloride injections[4].

Pediatric Considerations

In pediatric patients, especially those under 12 years old and down to neonates, the formulation must be carefully adjusted. The proposed dosing regimen for potassium phosphates, for example, involves weight-based dosing to ensure safety and efficacy in this vulnerable population. This approach is supported by published literature and clinical practice guidelines[4].

Ongoing Research

While specific clinical trials focused solely on the combination of amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride may not be widely reported, ongoing research in parenteral nutrition often involves studying the efficacy and safety of various electrolyte and nutrient combinations. For example, studies on the use of parenteral nutrition in critically ill patients and those with specific metabolic disorders continue to evolve, providing valuable insights into optimal formulations and dosing strategies[5].

Market Analysis

Demand and Growth

The demand for parenteral nutrition solutions is driven by the increasing number of patients requiring nutritional support due to various medical conditions, such as gastrointestinal disorders, cancer, and critical illnesses. The global parenteral nutrition market is expected to grow significantly, driven by advancements in formulation technology, increasing awareness of nutritional therapy, and the rising incidence of chronic diseases.

Market Segmentation

The market can be segmented based on the type of nutrients (amino acids, electrolytes, vitamins, and minerals), the patient population (adults, pediatrics), and the delivery method (central venous infusion, peripheral infusion). The segment involving amino acids and electrolytes, such as the formulation in question, is particularly important due to its critical role in maintaining electrolyte balance and supporting metabolic functions.

Key Players

Major players in the parenteral nutrition market include Fresenius Kabi, Baxter International, and B. Braun Melsungen. These companies are continuously innovating and expanding their product portfolios to meet the diverse needs of patients requiring parenteral nutrition.

Market Projections

Global Market Size

The global parenteral nutrition market is projected to reach significant growth over the next decade, with estimates suggesting a compound annual growth rate (CAGR) of around 5-7%. This growth is driven by increasing healthcare expenditures, advancements in medical technology, and the expanding need for nutritional support in various clinical settings.

Regional Analysis

The market is expected to grow across various regions, with North America and Europe leading due to their well-established healthcare systems and high adoption rates of advanced nutritional therapies. However, emerging markets in Asia-Pacific and Latin America are also expected to contribute significantly to the growth, driven by improving healthcare infrastructure and increasing awareness of parenteral nutrition.

Key Components and Their Roles

Amino Acids

Amino acids are essential for protein synthesis and are a critical component of parenteral nutrition solutions. They support tissue repair, immune function, and overall metabolic health[5].

Magnesium Chloride

Magnesium is a vital electrolyte that acts as a cofactor for numerous enzymatic reactions, maintains normal central nervous system activity, and supports amino acid utilization[1].

Potassium Phosphate Dibasic

Potassium phosphate is crucial for maintaining electrolyte balance, supporting renal function, and contributing to the metabolic processes. It is particularly important in preventing hypophosphatemia in patients with restricted or no oral intake[4].

Sodium Chloride

Sodium chloride helps maintain fluid balance, supports motor nerve depolarization, and is essential for normal renal metabolism. It is the principal extracellular cation and plays a key role in maintaining proper anion balance[1].

Clinical Use and Administration

Indications

Parenteral nutrition solutions containing amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride are indicated for patients who require nutritional support due to inability to receive nutrition through the gastrointestinal tract. This includes patients with severe gastrointestinal disorders, those undergoing major surgery, and critically ill patients[5].

Administration

These solutions are typically administered via central venous infusion to ensure the delivery of concentrated nutrients directly into the bloodstream. The formulation must be carefully diluted and adjusted according to the patient's specific needs to avoid complications such as hyperkalemia, hypernatremia, or other electrolyte imbalances[1].

Challenges and Considerations

Electrolyte Balance

Maintaining proper electrolyte balance is crucial when administering parenteral nutrition. Electrolytes such as potassium, magnesium, and sodium must be carefully monitored to avoid complications like cardiac arrhythmias or muscle weakness[1].

Renal Function

Patients with renal insufficiency require special consideration when administering parenteral nutrition. The formulation and dosing must be adjusted to avoid overloading the kidneys with electrolytes and nutrients that they may not be able to process effectively[5].

Physical Compatibility

Ensuring the physical compatibility of the various components of the parenteral nutrition solution is essential to avoid precipitation or other incompatibilities that could lead to adverse effects. For example, adding phosphate supplements to the solution requires careful consideration to avoid precipitation with calcium[1].

Key Takeaways

  • Clinical Trials: While specific trials on this exact formulation may be limited, the safety and efficacy are supported by extensive clinical experience with similar formulations.
  • Market Growth: The global parenteral nutrition market is expected to grow significantly, driven by increasing demand and advancements in formulation technology.
  • Key Components: Amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride each play critical roles in maintaining metabolic health and electrolyte balance.
  • Administration: Central venous infusion is the typical method of administration, requiring careful dilution and adjustment based on patient needs.
  • Challenges: Maintaining electrolyte balance, considering renal function, and ensuring physical compatibility are key challenges in the administration of these solutions.

FAQs

Q: What are the primary indications for parenteral nutrition solutions containing amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride?

A: These solutions are indicated for patients who require nutritional support due to inability to receive nutrition through the gastrointestinal tract, including those with severe gastrointestinal disorders, undergoing major surgery, or critically ill.

Q: How are these solutions typically administered?

A: These solutions are typically administered via central venous infusion to ensure the delivery of concentrated nutrients directly into the bloodstream.

Q: What are the key considerations for maintaining electrolyte balance in parenteral nutrition?

A: Electrolytes such as potassium, magnesium, and sodium must be carefully monitored to avoid complications like cardiac arrhythmias or muscle weakness. Patients with renal insufficiency require special consideration to avoid overloading the kidneys.

Q: What are the potential complications of administering parenteral nutrition solutions?

A: Potential complications include hyperkalemia, hypernatremia, other electrolyte imbalances, and physical incompatibilities leading to precipitation.

Q: How does the market for parenteral nutrition solutions project to grow in the future?

A: The global parenteral nutrition market is projected to grow significantly over the next decade, driven by increasing healthcare expenditures, advancements in medical technology, and the expanding need for nutritional support in various clinical settings.

Sources

  1. Pfizer Labeling: TPN Electrolytes (multiple electrolyte additive) - Labeling Information.
  2. AACR Journals: Interactions of Tyrosine Kinase Inhibitors with Organic Cation Transporters.
  3. FDA: Part I - FDA.
  4. FDA: 212832Orig1s000 - Potassium Phosphates Injection.
  5. ASHP: Strategies for Successful Parenteral Nutrition Order Writing.

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