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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01462669 | Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects | PHASE1 | COMPLETED | 1 | — | — | Apr 10, 2012 | Jun 27, 2012 | Jun 19, 2018 | 1 | Taiwan |
Peak plasma concentration (Cmax) of ezogabine/retigabine; and area under the plasma concentration-time curve from time zero to infinity (AUC(0-∞)) for ezogabine/retigabine
| Arm | Type | Description |
|---|---|---|
| Treatment Period 1 | OTHER | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 2 | OTHER | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 3 | OTHER | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 4 | OTHER | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Name | Type | Description |
|---|---|---|
| 50mg Ezogabine/retigabine | DRUG | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 100mg Ezogabine/retigabine | DRUG | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 200mg Ezogabine/retigabine | DRUG | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 400mg Ezogabine/retigabine | DRUG | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female between 20 and 65 years of age inclusive, at the time of signing the informed consent. 2. Taiwanese ancestry defined as being born in Taiwan, having four ethnic...