Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02201316 | A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 18 | — | — | Feb 3, 2014 | Mar 18, 2014 | May 15, 2017 | 1 | India |
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 \[AUC(0-t)\]
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Inclusion Criteria: * Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ...