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This study aims to determine the relative bioavailability of two candidate formulations of mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg) from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an open-label, randomised, single dose, three-way crossover, six sequence study. Subjects will receive a single oral dose separated by at least 7 days and no greater than 14 days washout period. This study is required to select a candidate mosapride citrate (GR107719B) formulation for further development and provide data to allow the design of a future pivotal bioequivalence study. The candidate formulations will be compared with the innovator GASMOTIN. GASMOTIN is a trademark of Dainippon Sumitomo Pharmaceutical Company.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABC) | Experimental | Subjects will receive treatments in the sequence ACB where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Sequence 2 (ACB) | Experimental | Subjects will receive treatments in the sequence ACB where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Sequence 3 (BAC) | Experimental | Subjects will receive treatments in the sequence BAC where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference mosapride citrate (GASMOTIN) | Drug | Reference mosapride citrate (GASMOTIN) 5mg will be supplied as caplet shaped tablet embossed with P218 and film-coated; administer orally with approximately 240 mL of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetics (PK) parameters of mosapride following administration of two candidate tablet formulations of mosapride citrate (GR107719B) relative to reference mosapride citrate (GASMOTIN) | PK parameters include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)] and area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)] | Day 1 of each treatrment period (Pre dose and 0.25 hour (h), 0.5 h, 0.75 h, 1 h, 1.33 h, 1.67 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of two candidate tablet formulations of mosapride citrate (GR107719B) relative to reference mosapride citrate tablets (GASMOTIN) | PK parameters include: Percentage of AUC (0-∞) obtained by extrapolation (%AUCex) time of occurrence of Cmax (tmax), terminal phase half-life (t1/2). | Day 1 of each treatrment period (Pre dose and 0.25 hour (h), 0.5 h, 0.75 h, 1 h, 1.33 h, 1.67 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h post dose) |
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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 200940 can be found on the GSK Clinical Study Register. | View source |
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| Sequence 4 (BCA) | Experimental | Subjects will receive treatments in the sequence BCA where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Sequence 5 (CAB) | Experimental | Subjects will receive treatments in the sequence CAB where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Sequence 6 (CBA) | Experimental | Subjects will receive treatments in the sequence CBA where, A=Single dose of reference mosapride citrate 5mg (GASMOTIN); B= Single dose of formulation 1 GR107719B 5mg (mosapride citrate); C= Single dose of formulation 2 GR107719B 5mg (mosapride citrate). All treatments will be administered orally in fasted state. Each treatment will be separated by a washout period of at least 7 days and no more than 14 days. |
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| GR107719B (Formulation 1) | Drug | GR107719B (Formulation 1) 5 mg will be supplied as L-HPC disintegrant caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water. |
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| GR107719B (Formulation 2) | Drug | GR107719B (Formulation 2) 5 mg will be supplied as caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water. |
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| Safety and tolerability assessment as assessed by review of adverse events (AEs) | Up to 51 days |
| Safety and tolerability assessment as assessed by vital signs | Vital sign measurements will include systolic and diastolic blood pressure, and pulse rate. | Up to 51 days |
| Safety and tolerability assessment as assessed by clinical laboratory values | Clinical laboratory assessments will include hematology, clinical chemistry, routine urinalysis and additional parameters. | Up to 51 days |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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