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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649324 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's hydrochlorothiazide 50 mg tablets to Ivax's Hydrochlorothiazide 50 mg tablets following a single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Hydrochlorothiazide Tablets 50 mg Drug: Hydrochlorothiazide Tablets (50 mg |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Fasting In-Vivo Bioequivalence Study of Hydrochlorothiazide Tablets (50 mg; Mylan) to Hydrochlorothiazide Tablets (50 mg; Ivax) in Healthy Volunteers |
| Enrollment: | 40 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Hydrochlorothiazide Tablets 50 mg
|
Drug: Hydrochlorothiazide Tablets 50 mg
50mg, single dose fasting
|
|
Active Comparator: 2
Hydrochlorothiazide Tablets 50 mg
|
Drug: Hydrochlorothiazide Tablets (50 mg
50mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649324 History of Changes |
| Other Study ID Numbers: | HCTZ-0588 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Hydrochlorothiazide Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |