Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: COREG® 25 mg tablets; Drug: Carvedilol 25 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834873

01269

Details and patient eligibility

About

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.

Full description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Carvedilol

Experimental group

Description:

Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period

Treatment:

Drug: Carvedilol 25 mg tablets

Coreg®

Active Comparator group

Description:

Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Treatment:

Drug: COREG® 25 mg tablets