NCT05339295

Bioequivalence Study of Levomerc 500 mg Tablets

Bioequivalence Study of Levomerc (Levofloxacin) 500 mg Tablet With Tavanic (Levofloxacin) 500 mg Tablets

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

Summary

An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.

Detailed description

The study will be conducted on 24 healthy subjects. The study will comprise of two Periods, I and II, each consisting of 36 hours, 12 hours before and 24 hour after the drug administration. All 24 subjects divided in group of 12 each. One group treated with the test (T) and other one with reference (R) drug in Period I and after the wash out period, the same received the alternate treatment in Period II. blood samples will be collected for up to 24 hours post dose in each period for plasma analysis of Levofloxacin.

Conditions

• Healthy
• Pharmacokintetics

Interventions

Type	Name	Description
DRUG	Levofloxacin 500mg	A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.

Timeline

• Start date: 2012-07-11
• Primary completion: 2012-07-20
• Completion: 2012-09-20
• First posted: 2022-04-21
• Last updated: 2022-09-07

Locations

1 site across 1 country: Pakistan