drugset / Trial / NCT00834873
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
RandomizedCrossoverOpen-labelOther
Summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 24 adult individuals under fed conditions.
Timeline
- Start
- 2001-12
- Primary completion
- 2001-12
- Completion
- 2001-12
Outcome
Met primary endpoint
registry Test/Ref Ratio of LS Means x 100 94.77 (90% CI 85.04 to 105.61) NCT00834873 ↗
registry Test/Ref Ratio of LS Means x 100 96.23 (90% CI 90.59 to 102.23) NCT00834873 ↗
registry Test/Ref Ratio of LS Means x 100 96.11 (90% CI 90.45 to 102.12) NCT00834873 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carvedilol | Other / unclassified | 25 mg | Oral |
Indications
No indication recorded.