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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01415349 | SSP-002358 Drug Interaction Study With Omeprazole | PHASE1 | COMPLETED | 42 | — | — | Aug 11, 2011 | Sep 28, 2011 | Jun 10, 2021 | 1 | Netherlands |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
| Arm | Type | Description |
|---|---|---|
| SSP-002358 alone | EXPERIMENTAL | - |
| SSP-002358 + omeprazole | EXPERIMENTAL | SSP-002358 + omeprazole |
| Name | Type | Description |
|---|---|---|
| SSP-002358 | DRUG | 1 mg, oral, once |
| SSP-002358 + omeprazole | DRUG | SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once |
Inclusion criteria: 1. Age 18-55 years inclusive at the time of consent. 2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: * Male, or * Non-pregnant, non-lactating female * Females must be at least 90 days post-partum or nulliparous. E...