|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| 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 |
|---|---|
|
1: Experimental
Hydrochlorothiazide Tablets 50 mg
|
Drug: Hydrochlorothiazide Tablets 50 mg
50mg, single dose fasting
|
|
2: Active Comparator
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: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | HCTZ-0588 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649324 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Sodium Chloride Symporter Inhibitors Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions |