Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions
- Conditions
- Ulcers, Duodenal and Gastric
- Interventions
- Registration Number
- NCT01847417
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fed conditions. For fed condition, after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories) after which they will be required to fast overnight (for at least 10 hours). Thereafter they will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Overall Study Arm Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two 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 Overall Study Arm Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one 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 Overall Study Arm ASA 100 mg tablet 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 Overall Study Arm Pantoprazole 20 mg gastro-resistant tablet 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
- Primary Outcome Measures
Name Time Method Composite of pharmacokinetic (PK) parameters During each period at pre-dose, 0.167, 0.333, 0.5, 0.667, 0.833, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16 and 24 hrs post dose 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
- Secondary Outcome Measures
Name Time Method Tolerability of combined ASA and pantoprazole in subjects during the study Up to 16 days Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and ECG
Trial Locations
- Locations (1)
GSK Investigational Site
🇮🇳Hyderabad, India