Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: clarithromycin 250 mg tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Ranbaxy Research Laboratories, Gurgaon, Haryana 122001, India
Additional Information
Starting date: July 2003
Last updated: October 16, 2008
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