|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00647660 |
The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
Healthy |
Drug: Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg Drug: Corzide® Tablets 80 mg/5 mg |
Phase I |
ChemIDplus related topics: | Bendroflumethiazide Nadolol |
Study Type: | Interventional |
Study Design: | Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting Bioequivalence Study of Nadolol/Bendroflumethiazide Tablets (80 mg/5 mg; Mylan) to Corzide® Tablets (80 mg/5 mg; King) in Healthy Volunteers |
Enrollment: | 66 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg
|
Drug: Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg
80/5mg, single dose fasting
|
2: Active Comparator
Corzide® Tablets 80 mg/5 mg
|
Drug: Corzide® Tablets 80 mg/5 mg
80/5mg, single dose fasting
|
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 use an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
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 |
Mylan Pharmaceuticals |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | NABE-0626 |
First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00647660 |
Health Authority: | United States: Institutional Review Board |
|
|
|