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Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00774189
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Tracking Information
First Submitted Date  ICMJE October 15, 2008
First Posted Date  ICMJE October 17, 2008
Last Update Posted Date October 17, 2008
Study Start Date  ICMJE July 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
Bioequivalence
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
Official Title  ICMJE 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
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: clarithromycin 250 mg tablets
Study Arms  ICMJE
  • Experimental: 1
    clarithromycin 250 mg tablets of Ranbaxy Laboratories
    Intervention: Drug: clarithromycin 250 mg tablets
  • Active Comparator: 2
    Biaxin 250 mg tablets
    Intervention: Drug: clarithromycin 250 mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00774189
Other Study ID Numbers  ICMJE 020/CLARI-250/03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Tausif monif, Ranbaxy Research Labs
Study Sponsor  ICMJE Ranbaxy Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ranbaxy Inc.
Verification Date October 2008

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