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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
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.
Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh, Pakistan
maximum plasma drug concentration
maximum drug concentration in plasma after dosing
Time frame: up to 24 hours post dose
AUC last (AUC 0-t)
Area under plasma concentration time curve from zero to time of the last measurable concentration
Time frame: 0 to 24 hours post dose
AUC total (AUC 0-∞)
area under the plasma concentration-time curve from zero to infinity.
Time frame: 0 to 24 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Time frame: up to 24 hours post dose
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