NCT05436769

Bioequivalence Study of Klaribact (Clarithromycin) 500 mg, Film Coated Tablet

An Open Label, Randomized, Single Dose, Two-way Crossover , Two-Period, Two-Treatment, Two-Sequence Bioequivalence Study of Klaribact Tablet (Clarithromycin 500 mg), Compared With Reference Product, Klaricid Tablet (Clarithromycin 500 mg) in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Karachi · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is An Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of Klaribact FC Tablet (Clarithromycin 500 mg) with Reference Product, Klaricid FC Tablet (Clarithromycin 500 mg) in healthy adult male subjects under fasting condition.

Detailed description

The study will be conducted on 24 healthy adult male subjects in two Periods i.e. period I and II. The study subjects will stay at the clinical trial site for 35 hours, 11 hours before and 24 hours after the drug administration. All 24 subjects will be divided in two groups of 12 subjects in each group. One group will be treated with the test drug (T) and the other one with reference drug (R) in Period I. After the wash-out period of 7 days, the volunteers in these groups will receive the alternate treatment sequence (RT) in Period II. Blood samples will be collected at 0 hr (before drug administration) 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 16 and 24 hours after drug administration for quantification of Clarithromycin in plasma through LCMS/MS validated method.

Conditions

• Healthy Volunteers
• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Klaribact 500 mg Clarithromycin Tablet	A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.
DRUG	Klaricid 500 mg Clarithromycin Tablet	A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.

Timeline

• Start date: 2012-10-23
• Primary completion: 2012-11-02
• Completion: 2012-12-25
• First posted: 2022-06-29
• Last updated: 2022-09-07

Locations

1 site across 1 country: Pakistan