At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Carvedilol 25 mg tablets +1 moredrug
Likely dose
Carvedilol 25 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Two-Way Crossover, Single-Dose, Open Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Carvedilol (25 mg), Compared to an Equivalent Dose of COREG® (SmithKline Beecham Pharmaceuticals) in 36 Fasted, Healthy, Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Carvedilol 25 mg tablets and COREG® 25 mg tablets for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2001
Primary CompletionDec 2001
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartDec 1, 2001
Primary CompletionDec 1, 2001
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Carvedilol 25 mg tabletsdrug
1 x 25 mg
COREG® 25 mg tabletsdrug
1 x 25 mg