A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Fasting Conditions

NCT00864435 | Completed Phase 1

• 1 other identifier: 3159
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Carvedilol; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  36 hours

Study Arms (2)

A

EXPERIMENTAL

Carvedilol 12.5 mg Tablets, single dose

Drug: Carvedilol 12.5 mg Tablets, single dose

B

ACTIVE COMPARATOR

Coreg® 12.5 mg Tablets , single dose

Drug: Coreg® 12.5 mg Tablets , single dose

Interventions

Carvedilol 12.5 mg Tablets, single dose DRUG

A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fasting conditions

A

Coreg® 12.5 mg Tablets , single dose DRUG

B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fasting conditions

Also known as: Carvedilol

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking male or female with a minimum age of 18 years.
• Body Mass Index (BMI = weight/heigh2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
• Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 106-140/66-90 mmHg, heart rate between 60-99 beats/minute, temperature between 35.8°C and 37.5°C)
• Negative for drugs of abuse and nicotine.
• Negative for hepatitis B-surface antigen, hepatitis C and HIV.
• Female subjects: negative for pregnancy (as evaluated by serum ß-CG test).
• No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides that they are not clinically significant.
• Female subjects who were surgically sterile for at least 6 months or post-menopausal for at least 1 year, or avoided pregnancy for at least 10 days before the study, during the study and up until 1 month after the end of the study.
• Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF

You may not qualify if:

• Known history of hypersensitivity to carvedilol (e.g. Coreg®) and/or related beta¬blockers such as propranolol (Inderal®, nadolol (Corgard®), labetalol (Trandate®, metoprolol (Lopressor®, Betaloc®, atenolol (Tenormin®, sotalol, timolol, pindolol, or acebutolol.
• Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
• Presence of any significant physical or organ abnormality.
• Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
• Known history of frequent headaches or migraines.
• Known history of chronic bronchitis or any bronchospastic condition.
• Any clinically significant illness during the 4 weeks before this study.
• Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
• Significant or recent history of asthma (after 12 years of age).
• Any subject with a history of drug abuse.
• Any subject with a recent (less than 1 year) history of alcohol abuse.
• Use of any prescription medication within 14 days preceding this study.
• Use of any over-the-counter (OTC) cough and cold medication containing dextromethorphan within 14 days preceding this study.
• Use of OTC medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Biovail Contract Research (A Division of Biovail Corporation)

Toronto, Ontario, M1L 4S4 / M1L 4R6, Canada

Location

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Paul Y. Tam,, MD

  Biovail Contract Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: October 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

CA (1)