- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00774189
Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
October 16, 2008 updated by: Ranbaxy Laboratories Limited
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
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
Study Overview
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
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Gurgaon, Haryana, India, 122001
- Ranbaxy Research Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 India 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 14 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 (IUD), 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 clarithromycin, erythromycin and related macrolides
- 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 and syphilis infection.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breastfeeding.
- 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
- 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) 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
- 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).
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- 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 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.
- Use of any enzyme modifying drugs within 30 days prior to Day I of this study
- Participation in any clinical trial within 12 weeks preceeding day 1 of study
- Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in past 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
clarithromycin 250 mg tablets of Ranbaxy Laboratories
|
|
ACTIVE_COMPARATOR: 2
Biaxin 250 mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequivalence
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (ACTUAL)
August 1, 2003
Study Completion (ACTUAL)
November 1, 2003
Study Registration Dates
First Submitted
October 15, 2008
First Submitted That Met QC Criteria
October 16, 2008
First Posted (ESTIMATE)
October 17, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 17, 2008
Last Update Submitted That Met QC Criteria
October 16, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020/CLARI-250/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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