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Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00776113
First received: October 16, 2008
Last updated: October 17, 2008
Last verified: October 2008

October 16, 2008
October 17, 2008
August 2003
September 2003   (final data collection date for primary outcome measure)
Bioequivalence [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776113 on ClinicalTrials.gov Archive Site
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Not Provided
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Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions
An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Carvedilol Formulations Comparing Carvedilol 12.5 mg Tablets of Ranbaxy Laboratories With Coreg® 12.5 mg Tablets of Glaxosmithkline in Healthy, Adult, Human Subjects Under Fasting Conditions

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

The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc, USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in healthy, adult, male, human subjects under fasting condition.

Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Thirty-six subjects completed both the periods of the study

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: Carvedilol 12.5 mg tablets
bioequivalence Carvedilol fasting
  • Active Comparator: 2
    Carvedilol 12.5 mg tablets
    Intervention: Drug: Carvedilol 12.5 mg tablets
  • Experimental: 1
    Carvedilol 12.5 mg tablets
    Intervention: Drug: Carvedilol 12.5 mg tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2003
September 2003   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00776113
021/CARVE-12.5/03
Yes
Dr. Tausif Monif, Ranbaxy Research laboratories
Ranbaxy Laboratories Limited
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Ranbaxy Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP