NCT05340452

Bioequivalence Study of Klaribact 125mg/5ml, Suspension

An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study of Klaribact (Clarithromycin) 125mg/5ml Suspension Compared With Klaricid (Clarithromycin) 125mg/5ml Suspension in 24 Healthy Adult Subjects Under Fasting Condition.

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

Summary

A two way crossover BE study will be performed to evaluate the comparative bioavailability of Klaribact (Clarithromycin 125 mg/5ml) suspension (Merck Pvt. Ltd, Pakistan) with Klaricid (Clarithromycin 125mg/5ml) suspension (Abbot Laboratories Pakistan Limited) at the clinical site (CBSCR), Karachi Pakistan.

Detailed description

The Bioequivalence study of Klaribact Suspension will be conducted on 24 healthy participants. Finally selected subjects will be divided into two groups, Group A and Group B, with 12 subjects in each group. The study will be consisted of two periods, Period I and Period II, each comprising of 35 hours, 11 hours before and 24 hours after the drug administration. A washout period of 6 days will be provided between the two periods to ensure the absence of carry over effect. Each group (A \& B) will be treated with either of the two sequences, TR or RT, in Period I and the sequence will be inter-changed in Period II. blood samples from each volunteer will be collected at specific time points to analyze plasma concentration of Clarithromycin.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Klaribact 125mg/5ml Suspension	one single 20 mL dose (500mg) of the test drug will be administered to the volunteers
DRUG	Klaricid 125mg/5ml Suspension	one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers

Timeline

• Start date: 2013-06-29
• Primary completion: 2013-07-08
• Completion: 2013-10-25
• First posted: 2022-04-22
• Last updated: 2022-04-29

Locations

1 site across 1 country: Pakistan