Status:
COMPLETED
A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Fasting Conditions
Lead Sponsor:
Actavis Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Detailed Description
Study Type: Interventional Study Design: Two-way crossover, randomized, open-label, single-dose, fasting, bioequivalence study Official Title: A Two-Way Crossover, Open-Label, Single Dose, Fasting, B...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- Female subjects: use of contraceptives (oral, emergency \[plan B®, transdermal, implant, Mirena® IUD, NuvaRing®) within 30 days before drug administration or a depot injection of progestogen drug (e.g. Depo-Provera® within 1 year before drug administration.
- Female subjects: evidence of pregnancy or lactation.
- Any subject who had blood drawn within 56 days preceding this study, during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- Participated in a clinical trial with an investigational drug within 30 days preceding this study.
- Any subject who had donated blood within 56 days preceding this study.
- Any subject who had participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
- Intolerance to venipuncture.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00864435
Start Date
October 1 2005
End Date
November 1 2005
Last Update
August 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Biovail Contract Research (A Division of Biovail Corporation)
Toronto, Ontario, Canada, M1L 4S4 / M1L 4R6