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

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, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Inclusion criteria

• 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 criteria

• 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.