drugset
drugset / Trial / NCT00834795

Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

NCT00834795 ↗

Phase 1 Completed 36 enrolled Teva Pharmaceuticals USA
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 36 adult individuals under fasting conditions.

Timeline

Start
2001-12
Primary completion
2001-12
Completion
2001-12

Outcome

Met primary endpoint

registry analysis (unspecified test); Carvedilol vs Coreg®; Test/Ref Ratio of LS Means x 100 95.16 (90% CI 85.69 to 105.67) NCT00834795 ↗

registry analysis (unspecified test); Carvedilol vs Coreg®; Test/Ref Ratio of LS Means x 100 96.27 (90% CI 90.34 to 102.59) NCT00834795 ↗

registry analysis (unspecified test); Carvedilol vs Coreg®; Test/Ref Ratio of LS Means x 100 96.36 (90% CI 90.20 to 102.93) NCT00834795 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carvedilol Other / unclassified 25 mg Oral

Indications

No indication recorded.