This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg
One (1) capsule of Rifampicin 300 mg
Pfizer Investigational Site
Dasmariñas, Philippines
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Plasma Decay Half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)
AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC \[0-∞\] minus AUC\[0-10\])\*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.
Time frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
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