Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in healthy, adult, human subjects under fed conditions.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Be in the' age range of 18-45 years.

• Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of lndia height/weight chart for non-medical cases.

• Have voluntarily given written informed consent to participate in this study.

• Be of normal health as determined by medical history and physical examination of the subjects performed within :1.4 days prior to the commencement of the study.

If female and:

• Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device ([UD), or abstinence; or Is postmenopausal for at least 1 year; or

• Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

• History of allergy to 13-adrenoceptor antagonists especially carvedilol.

• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.

• Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses or syphilis infection.

• Female volunteers demonstrating a positive pregnancy test.

• Female volunteers who are currently breastfeeding.

• Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.

Positive for urinary screen testing of drugs of abuse (opiates And cannabinoids)

• Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.

• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).

• Clinically abnormal ECG or Chest X-ray.

• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma, bronchial asthma, fainting or syncope.

• History of any psychiatric illness which may impair the ability to provide written informed consent.

• Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.

• History of drug dependence or excessive alcohol intake on Habitual basis of more than 2 units of alcoholic beverages per day (1 Unit equivalent to half pint of beer or ! glass of wine or I measure of spirit) or have difficulty_ in abstaininq for the duration of each study period.

• Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.

• Participation in any clinical trial within 12 weeks preceding Day 1 of this study.

• A haemoglobin concentration of less than 7 % of lower limit of reference range e.g. 13 gm % for reference range of 1448 gm at screening.