Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Carvedilol 25 mg tablets
* Drug: COREG® 25 mg tablets


Participation Criteria
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Eligibility Criteria
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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. Females who are pregnant or lactating History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug. Conditions upon screening which might contraindicate or require that caution be used in the administration of carvedilol, including: sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg. Heart rate less than 60 beats per minute after a 5-minute rest in a seated position. Inability to read and/or sign the consent form. Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study. Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums,etc.) Ninety (90) days abstinence is required. subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol<br>Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period | Drug: Carvedilol 25 mg tablets<br>* 1 x 25 mg<br>|
| Active Comparator: Coreg®<br>Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period | Drug: COREG® 25 mg tablets<br>* 1 x 25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration - Carvedilol in Plasma | Bioequivalence based on Cmax | Blood samples collected over 60 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma | Bioequivalence based on AUC0-inf | Blood samples collected over 60 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma | Bioequivalence based on AUC0-t | Blood samples collected over 60 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects