Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00775619 |
The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in healthy, adult, human subjects under fed conditions.
Condition | Intervention |
---|---|
Healthy |
Drug: Carvedilol 12.5 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Carvedilol Formulations Comparing Carvedilol 12.5 mg Tablets of Ranbaxy Laboratories With Coreg® 12.5 mg Tablets of Glaxosmithkline in Healthy, Adult, Human Subjects Under Fed Conditions |
Enrollment: | 40 |
Study Start Date: | September 2003 |
Study Completion Date: | December 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator
Coreg® 12.5 mg tablets
|
Drug: Carvedilol 12.5 mg tablets
bioequivalence Carvedilol 12.5 mg tablets fed conditions
|
1: Experimental
Carvedilol 12.5 mg tablets
|
Drug: Carvedilol 12.5 mg tablets
bioequivalence Carvedilol 12.5 mg tablets fed conditions
|
The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc, USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in healthy, adult, male, human subjects under fed condition.
Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Thirty-nine subjects completed both the periods of the study
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
If female and:
Exclusion Criteria:
Positive for urinary screen testing of drugs of abuse (opiates And cannabinoids)
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 023/CARVE-12.5/03 |
Study First Received: | October 16, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775619 |
Health Authority: | India: drug controller general india |
bioequivalence Carvedilol 12.5 mg tablets fed conditions |
Malnutrition Healthy Carvedilol |
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |