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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03069963 | PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects | PHASE1 | COMPLETED | 24 | — | — | Feb 24, 2017 | Apr 23, 2017 | May 12, 2022 | 1 | France |
| NCT03065816 | Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects | PHASE1 | COMPLETED | 34 | — | — | Feb 9, 2017 | May 2, 2017 | Apr 25, 2022 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Sequence 1 (Z0063 to Gaviscon) | EXPERIMENTAL | The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose |
| Sequence 2 (Gaviscon to Z0063) | EXPERIMENTAL | The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose |
| Name | Type | Description |
|---|---|---|
| Z0063 | DRUG | Pharmaceutical form: chewable tablets Route of administration: oral |
| Gaviscon | DRUG | Pharmaceutical form: chewable tablets Route of administration: oral |
Inclusion criteria : * Male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive. * Certified as healthy by a comprehensi...