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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh, Pakistan
maximum plasma concentration
maximum drug concentration in plasma after dose
Time frame: up to 24 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Time frame: 0 to 24 hours post dose
AUC
Area under the time versus plasma drug concentration curve
Time frame: 0-2 4hours
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