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

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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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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