Overview

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.