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Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
This study has been completed.
Sponsored by: Ranbaxy Laboratories Limited
Information provided by: Ranbaxy Inc.
ClinicalTrials.gov Identifier: NCT00774189
  Purpose

The objective of the study was to compare the single-dose oral bioavailability of Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott Laboratories in healthy, adult, human subjects under fasting conditions


Condition Intervention Phase
Healthy
Drug: clarithromycin 250 mg tablets
Phase I

Drug Information available for: Clarithromycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title: An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Clarithromycin Formulations, Comparing Clarithromycin 250 mg Tablets of Ranbaxy Laboratories With Biaxin 250 mg Tablets of Abbott Laboratories in Healthy, Adult, Human Subjects Under Fasting Conditions

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2003
Study Completion Date: November 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
clarithromycin 250 mg tablets of Ranbaxy Laboratories
Drug: clarithromycin 250 mg tablets
2: Active Comparator
Biaxin 250 mg tablets
Drug: clarithromycin 250 mg tablets

Detailed Description:

This was an open label, balanced, and randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study. Both periods were separated by a washout of twelve days The study was conducted on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be in the age range of 18-45 years.
  2. Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Have voluntarily given written informed consent to participate in this study.
  4. Be of normal health as determined by medical history and physical
  5. Examination of the subjects performed .within 14 days prior to the commencement of the study.
  6. 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 (IUD), or abstinence; or~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  1. History of allergy to clarithromycin, erythromycin and related macrolides
  2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  3. Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
  4. Female volunteers demonstrating a positive pregnancy screen.
  5. Female volunteers who are currently breastfeeding.
  6. Presence of values' which are clinically significantly different from normal reference ranges for haemoglobin, total white blood cells count, differential WBC count and platelet count
  7. Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
  8. Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol
  9. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive).
  10. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
  11. History of any psychiatric illness. which may impair the ability to provide written informed consent.
  12. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  13. History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 'unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
  14. Use of any enzyme modifying drugs within 30 days prior to Day I of this study
  15. Participation in any clinical trial within 12 weeks preceeding day 1 of study
  16. Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774189

Locations
India, Haryana
Ranbaxy Research Laboratories
Gurgaon, Haryana, India, 122001
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Ranbaxy Research Labs ( Dr. Tausif monif )
Study ID Numbers: 020/CLARI-250/03
Study First Received: October 15, 2008
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00774189  
Health Authority: India: Drugs Controller General of India

Keywords provided by Ranbaxy Inc.:
Bioequivalence clarithromycin 250mg tablets fasting

Study placed in the following topic categories:
Clarithromycin
Healthy

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009