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Bioequivalence Study of Levomerc 500 mg Tablets — BABE  

Healthy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05339295
Study type Interventional
Source University of Karachi
Contact
Status Completed
Phase Phase 1
Start date July 11, 2012
Completion date September 20, 2012
View Details
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