Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00775255
• Date of registration: 16/10/2008
• Prospective Registration: No
• Primary sponsor: Ranbaxy Laboratories Limited
• Public title: Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions
• Scientific title: An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover, Bioavailability Study on Clarithromycin Formulations Comparing Clarithromycin 250 mg/5 mL Powder for Oral Suspension of Ranbaxy Laboratories With Biaxin® Granules 250 mg/5 mL Oral Suspension in Healthy, Adult, Human, Male Subjects Under Fasting Conditions.
• Date of first enrolment: September 2005
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00775255
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

India

Key inclusion & exclusion 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 examination of the
subjects performed within 14 days prior to the commencement of the study.

Exclusion Criteria:

1. History of allergy to clarithromycin, erythromycin and related macrolides.

2. History of severe diarrhoea within 2 weeks preceding Day 1 of this study.

3. Any evidence of organ dysfunction or any clinically significant deviation from the
normal, in physical or clinical determinations.

4. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis
infection.

5. Presence of values which were significantly different from normal reference ranges
(as defined in Appendix 5) and/or judged clinically significant for haemoglobin,
total white blood cells count, differential WBC count or platelet count.

6. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)

7. Presence of values which were significantly different from normal reference ranges
(as defined in Appendix 5) and/or judged clinically significant for serum creatinine,
blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine
aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose
or serum cholesterol.

8. Clinically abnormal chemical and microscopic examination of urine defined as presence
of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).

9. Clinically abnormal ECG or Chest X-ray.

10. QTc interval beyond normal limits.

11. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary,
neurological or haematological disease, diabetes or glaucoma.

12. History of any psychiatric illness which might have impair the ability to provide
written informed consent.

13. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining
from smoking for the duration of each study period.

14. 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.

15. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.

16. Participation in any clinical trial within 12 weeks preceding Day 1 of this study.

17. Subjects who, through completion of this study, would have donated and/or lost more
than 350 mL of blood in the past 3 months.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: clarithromycin 250 mg/5 mL powder for oral suspension

Primary Outcome(s)

Bioequivalence [Time Frame: No]

Secondary ID(s)

CPU-M-025/CLARI-250/05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors