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| Name | Class |
|---|---|
| Piramal Clinical Research (Hyderabad, India) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic (PK) parameters | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of combined ASA and pantoprazole in subjects during the study | Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and ECG | Up to 16 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hyderabad | 500 013 | India |
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| Label | URL |
|---|---|
| Results for study 116498 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116498 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 116498 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116498 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116498 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116498 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116498 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D013607 | Tablets |
| D013608 | Tablets, Enteric-Coated |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003692 | Delayed-Action Preparations |
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