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Last Updated: October 24, 2020

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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.
>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
Hypercalciuria 2
Kidney Calculi 2
Healthy 2
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Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention Trials
Nephrolithiasis 4
Kidney Calculi 4
Hypercalciuria 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 22
India 3
Canada 3
Switzerland 2
United Kingdom 2
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Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location Trials
Maryland 3
Minnesota 3
Illinois 2
Texas 2
California 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 7
Phase 3 3
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 12
Recruiting 9
Not yet recruiting 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
National Institutes of Health (NIH) 2
University of California, San Francisco 2
University of Zurich 2
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Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor Trials
Other 44
NIH 8
Industry 4
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