|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649103 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Quinapril Hydrochloride Tablets 40 mg Drug: Accupril® Tablets 40 mg |
Phase I |
| 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 Quinapril Hydrochloride Tablets (40 mg; Mylan) and Accupril® Tablets (40 mg; Parke-Davis) in Healthy Volunteers |
| Enrollment: | 60 |
| Study Start Date: | December 2002 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Quinapril Hydrochloride Tablets 40 mg
|
Drug: Quinapril Hydrochloride Tablets 40 mg
40mg, single dose fasting
|
|
Active Comparator: 2
Accupril® Tablets 40 mg
|
Drug: Accupril® Tablets 40 mg
40mg, single dose fasting
|
Eligibility| 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:
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: | NCT00649103 History of Changes |
| Other Study ID Numbers: | QUIN-0290 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Quinapril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |