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Also known as Reference mosapride citrate (GASMOTIN)
Reference mosapride · 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 ...
Reference mosapride is a small molecule gastrointestinal agent developed by GSK plc (ticker GSK). It is being studied in gastritis and is in Phase 1 clinical development. In the one recorded trial it served as the comparator formulation of mosapride citrate against which candidate formulations were assessed.
Reference mosapride is being studied for gastritis, a gastrointestinal condition. The single registered trial enrolled healthy adult volunteers rather than patients, and its purpose was to compare the bioavailability of candidate mosapride formulations against the reference mosapride citrate tablet under fasting conditions.
Reference mosapride is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the compound and with the Phase 1 bioavailability study in which the reference mosapride citrate tablet was used as the comparator.
Reference mosapride is in Phase 1 clinical development. It is investigational and is not described as approved. One Phase 1 trial has been completed, and no trials are currently active, so the recorded clinical work consists of that single completed study.
Reference mosapride has been evaluated in one completed Phase 1 trial, NCT02201316. That randomized, controlled pilot study enrolled 18 healthy adult volunteers in India, ages 18 and older, of all sexes, and assessed the relative bioavailability of mosapride 5 mg from two candidate formulations compared with one 5 mg reference mosapride citrate tablet under fasting conditions.
Yes. Reference mosapride is also known as Reference mosapride citrate, marketed under the name GASMOTIN. The trial title refers to the reference mosapride citrate (GASMOTIN) 5 mg tablet, which was used as the comparator formulation in the Phase 1 bioavailability study.