This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions. In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1. PARIET is a registered trademark of EISAI Co. Limited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
70
IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.
GSK Investigational Site
Cairo, Egypt
Maximal Measured Plasma Concentration (Cmax) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Mean Terminal Half Life (t1/2) of Rabeprazole
Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.
Time frame: Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
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