CLINICAL TRIALS PROFILE FOR AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
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505(b)(2) Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
| 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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; 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 | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Condition Name
| Condition Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | |
| Intervention | Trials |
| Healthy | 3 |
| Hyperkalemia | 2 |
| Respiratory Distress Syndrome, Adult | 2 |
| [disabled in preview] | 0 |
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Condition MeSH
Clinical Trial Locations for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Trials by Country
Clinical Trial Progress for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Clinical Trial Phase
| Clinical Trial Phase for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | |
| Clinical Trial Phase | Trials |
| Phase 4 | 11 |
| Phase 3 | 4 |
| Phase 2/Phase 3 | 2 |
| [disabled in preview] | 0 |
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Clinical Trial Status
| Clinical Trial Status for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | |
| Clinical Trial Phase | Trials |
| Completed | 23 |
| Not yet recruiting | 7 |
| Terminated | 5 |
| [disabled in preview] | 0 |
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Clinical Trial Sponsors for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Sponsor Name
| Sponsor Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride | |
| Sponsor | Trials |
| University of Minnesota | 3 |
| University of Maryland, Baltimore | 2 |
| AstraZeneca | 2 |
| [disabled in preview] | 0 |
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