Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting Conditions

A Randomized,two-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions.

Treatment Duration: Single dose of the two treatments (A, B) in two different occasions, separated by a washout period of 7 days.

Inclusion Criteria:

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Website, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:

• Subjects will be females and/or males, smokers and non-smokers, 18 years of age & older.

• Female subjects will be post-menopausal/surgically sterilized.

  • Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
  • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

• Clinically significant illnesses/surgery within 4 weeks prior to the administration of study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Subjects with a clinically significant history of second- or third-degree AV block, sick sinus syndrome or severe bradycardia or in patients with cardiogenic shock who have decompensated heart failure.
• Subjects with history of hepatic failure.
• Presence or history of liver disease, cardiovascular disease, diabetes, hyperthyroidism aDd peripheral vascular disease.
• Positive urine drug screen or positive testing for hepatitis B, hepatitis C or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure \