Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test 1= ASA and pantoprazole formulation one · 2 trials · 1 indication
The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC\_% Extrap\_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments
| Arm | Type | Description |
|---|---|---|
| Overall Study Arm | EXPERIMENTAL | All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order in fed condition. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet |
| Name | Type | Description |
|---|---|---|
| Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one | DRUG | Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two | DRUG | Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| ASA 100 mg tablet | DRUG | Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany |
| Pantoprazole 20 mg gastro-resistant tablet | DRUG | Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany |
Inclusion criteria: * Healthy human subjects within the age range of 18 to 45 years (both inclusive) * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index (BMI) of \>=18.5 kilogram per meter square (kg/m\^2) and \<=24...
Test 1= ASA and pantoprazole formulation one is a fixed dose combination capsule containing acetylsalicylic acid 100 mg and pantoprazole 20 mg. It is a small molecule formulation developed by GSK plc for duodenal and gastric ulcers. It is an investigational product that has been studied in Phase 1 clinical trials.
Test 1= ASA and pantoprazole formulation one is being studied for duodenal and gastric ulcers. The capsule combines acetylsalicylic acid 100 mg with pantoprazole 20 mg in a single fixed dose formulation. Its clinical development has so far been limited to Phase 1 bioavailability studies in healthy volunteers.
Test 1= ASA and pantoprazole formulation one is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 clinical program for this fixed dose combination capsule of acetylsalicylic acid 100 mg and pantoprazole 20 mg.
Test 1= ASA and pantoprazole formulation one is in Phase 1 clinical development. Two Phase 1 trials have been completed, and neither is currently active. The program has enrolled 48 participants in total across those completed studies.
Test 1= ASA and pantoprazole formulation one has been evaluated in two completed Phase 1 bioavailability trials. NCT01847417 studied the capsule under fed conditions, and NCT01847404 studied it under fasting conditions. Both trials enrolled 24 healthy volunteers each in India and are now completed.