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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01342198 | An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2011 | Jul 1, 2011 | Jan 22, 2021 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Single Dose Pregabalin Controlled Release |
| 2 | EXPERIMENTAL | Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin |
| Name | Type | Description |
|---|---|---|
| Pregabalin controlled release, 330 mg | DRUG | A single oral dose of 330 mg controlled release tablet |
| erythromycin | DRUG | A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR |
Inclusion Criteria: * Healthy male or females * Between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Illicit drug use * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable me...