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 24 Fed, Healthy, Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Carvedilol 25 mg tablets
- Conditions
- Healthy
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax - Maximum Observed Concentration - Carvedilol in Plasma
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sex: Male of Female; similar proportions of each preferred.
- •Age: At least 18 years.
- •Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.
Exclusion Criteria
- •Subjects not complying with the above inclusion criteria must be excluded from the study.
- •In addition, any one of the conditions listed below will exclude a subject from the study.
- •History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
- •History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- •History of treatment for any gastrointestinal disorder within the past five (5) years.
- •History of, or presence of, asthma
- •History of peripheral vascular disease
- •History of heart failure
- •History of pre-existing cardiac arrythmias associated with tachycardia
- •History of severe sensitivity to allergens, requiring urgent medical treatment.
Arms & Interventions
Carvedilol
Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Intervention: Carvedilol 25 mg tablets
Coreg®
Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
Intervention: COREG® 25 mg tablets
Outcomes
Primary Outcomes
Cmax - Maximum Observed Concentration - Carvedilol in Plasma
Time Frame: Blood samples collected over 60 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
Time Frame: Blood samples collected over 60 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
Time Frame: Blood samples collected over 60 hour period
Bioequivalence based on AUC0-t