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Bioequivalence of Idiazole vs PARIET (Rabeprazole) in Healthy Adults
NCT02446483Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2014
- Primary completion
- Mar 2014
- Countries
- 1
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- rabeprazole
- Conditions
- gastrointestinal disease
01
Overview
Phase 4, randomised, open-label trial of rabeprazole in gastrointestinal disease (2 arms), sponsored by GSK. Primary endpoints: Mean Maximal Measured Plasma Concentration at 14 hours, Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration at 14 hours and 1 more. Started Mar 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Group A
Idiazole then PARIET
Group B
PARIET then Idiazole
03
Who it enrols
Healthy male or female adults aged 18-55 with normal BMI and no history of significant medical conditions, drug allergies, or substance abuse.
04
Endpoints
Primary
Mean Maximal Measured Plasma Concentration
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Secondary
Time of the Maximum Plasma Concentration
Terminal Half-life
Apparent First-order Elimination or Terminal Rate Constant
05
Results
Primary endpoints met
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