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Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774189
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: clarithromycin 250 mg tablets Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : July 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
clarithromycin 250 mg tablets of Ranbaxy Laboratories
Drug: clarithromycin 250 mg tablets
Active Comparator: 2
Biaxin 250 mg tablets
Drug: clarithromycin 250 mg tablets

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774189

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

Additional Information:
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Responsible Party: Dr. Tausif monif, Ranbaxy Research Labs Identifier: NCT00774189    
Other Study ID Numbers: 020/CLARI-250/03
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
Bioequivalence clarithromycin 250mg tablets fasting
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors