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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00649441 |
The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20 mg/25 mg tablets following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg Drug: Accuretic™ Tablets 20 mg/25 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Quinapril HCl and Hydrochlorothiazide Tablets (20 mg/25 mg; Mylan) to Accuretic™ Tablets (20 mg/25 mg; Parke-Davis) in Healthy Volunteers |
Enrollment: | 60 |
Study Start Date: | August 2003 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
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Drug: Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
20/25mg, single dose fasting
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2: Active Comparator
Accuretic™ Tablets 20 mg/25 mg
|
Drug: Accuretic™ Tablets 20 mg/25 mg
20/25mg, single dose fasting
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | QUTZ-0311 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00649441 |
Health Authority: | United States: Institutional Review Board |
Quinapril Healthy Hydrochlorothiazide |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Protease Inhibitors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors |