Trial Outcomes & Findings for Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions (NCT NCT02605395)
NCT ID: NCT02605395
Last Updated: 2018-10-01
Results Overview
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.
COMPLETED
PHASE4
70 participants
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
2018-10-01
Participant Flow
Bioequivalence of rabeprazole from Idiazole 20 milligram (mg) tablets and Pariet 20 mg tablets was investigated after single oral dose administration to healthy participants under fed conditions. This study was conducted from 22 March 2014 to 30 March 2014.
During this study, 74 participants were screened. One participant was excluded for significant variation in laboratory results at screening and three participants voluntarily withdrew before entering in to period 1. Hence, 70 participants were enrolled and randomized in study, and all 70 participants completed both periods of the study.
Participant milestones
| Measure |
Pariet 20 mg Followed by Idiazole 20 mg
Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablet in period 1 followed by Idiazole 20 mg gastro-resistant tablets in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.
|
Idiazole 20 mg Followed by Pariet 20 mg
Eligible participants received a single oral dose of Idiazole 20 mg gastro-resistant tablets in period 1 followed by Pariet 20 mg enteric coated tablet in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.
|
|---|---|---|
|
Period 1, Day 1
STARTED
|
35
|
35
|
|
Period 1, Day 1
COMPLETED
|
35
|
35
|
|
Period 1, Day 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period, Day 2 to Day 7
STARTED
|
35
|
35
|
|
Washout Period, Day 2 to Day 7
COMPLETED
|
35
|
35
|
|
Washout Period, Day 2 to Day 7
NOT COMPLETED
|
0
|
0
|
|
Period 2, Day 8
STARTED
|
35
|
35
|
|
Period 2, Day 8
COMPLETED
|
35
|
35
|
|
Period 2, Day 8
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Baseline characteristics by cohort
| Measure |
All Study Participants
n=70 Participants
Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablets or Idiazole 20 mg gastro-resistant tablets under fed condition in any of the 2 treatment periods. There was a 7 days washout interval between two study drug administration.
|
|---|---|
|
Age, Continuous
|
30.76 Years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 2Population: All subject population comprised of all participants who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Maximal Measured Plasma Concentration (Cmax) of Rabeprazole
|
393.50 Nanograms per milliliter
Standard Deviation 158.60
|
415.83 Nanograms per milliliter
Standard Deviation 179.24
|
PRIMARY outcome
Timeframe: 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 2Population: All subject population.
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole
|
812.30 Hour*nanograms per milliliter
Standard Deviation 461.30
|
843.68 Hour*nanograms per milliliter
Standard Deviation 425.21
|
PRIMARY outcome
Timeframe: 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 2Population: All subject population.
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole
|
798.59 Hour*nanograms per milliliter
Standard Deviation 314.16
|
931.81 Hour*nanograms per milliliter
Standard Deviation 442.17
|
SECONDARY outcome
Timeframe: 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 2Population: All subject population.
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole
|
3.93 Hour
Standard Deviation 1.06
|
3.86 Hour
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 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 2Population: All subject population
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole
|
0.21 Per hour
Standard Deviation 0.14
|
0.16 Per hour
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 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 2Population: All subject population
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.
Outcome measures
| Measure |
Idiazole 20 mg
n=70 Participants
Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
|
Pariet 20 mg
n=70 Participants
Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
|
|---|---|---|
|
Mean Terminal Half Life (t1/2) of Rabeprazole
|
4.49 Hour
Standard Deviation 2.40
|
5.81 Hour
Standard Deviation 3.08
|
Adverse Events
Idiazole 20 mg
Pariet 20 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER