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GR107719B · 1 trial · 1 indication
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 ...
GR107719B is an investigational small molecule being developed for the treatment of gastritis, a gastrointestinal condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its bioavailability and pharmacokinetic properties.
GR107719B is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational drug candidate for the treatment of gastritis.
GR107719B is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to evaluate its safety, tolerability, and pharmacokinetics in humans. The drug is not yet available for commercial use.
GR107719B has one completed Phase 1 clinical trial registered under NCT02201316. This study was a pilot bioavailability trial conducted in India with 18 healthy adult subjects. The trial compared two candidate formulations of GR107719B against a reference mosapride citrate tablet under fasting conditions.
GR107719B is an investigational drug candidate that contains mosapride, a gastroprokinetic agent. The Phase 1 clinical trial for GR107719B compared its bioavailability to a reference mosapride citrate tablet (GASMOTIN). GR107719B is being developed as a potential alternative formulation of mosapride for treating gastritis.
GR107719B contains mosapride, a gastroprokinetic agent that enhances gastrointestinal motility. It is being studied for the treatment of gastritis, a condition characterized by inflammation of the stomach lining. The drug is intended to improve gastric emptying and relieve symptoms associated with this gastrointestinal disorder.