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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00871806 | Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2009 | Apr 1, 2009 | Jan 27, 2021 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Eletriptan commercial tablet with water | ACTIVE_COMPARATOR | Eletriptan commercial tablet given with water |
| Eletriptan oral disintegrating tablet (ODT) #1 without water | EXPERIMENTAL | Oral disintegrating tablet formulation #1 without water |
| Oral disintegrating tablet formulation (ODT) #2 without water | EXPERIMENTAL | Oral disintegrating tablet formulation #2 without water |
| Oral disintegrating tablet formulation (ODT) #1 with water | EXPERIMENTAL | Oral disintegrating tablet formulation (ODT) #1 with water |
| Oral disintegrating tablet formulation (ODT) #2 with water | EXPERIMENTAL | Oral disintegrating tablet formulation (ODT) #2 with water |
| Name | Type | Description |
|---|---|---|
| Commercial tablet with water | DRUG | 40 mg tablet, given once to each subject |
| ODT #1 without water | DRUG | 40 mg tablet given once to each subject |
| ODT #2 without water | DRUG | 40 mg tablet given once to each subject |
| ODT #1 with water | DRUG | 40 mg tablet given once to each subject |
| ODT #2 with water | DRUG | 40 mg tablet given once to each subject |
Inclusion Criteria: * Healthy subjects * No CYP3A4 inhibitors Exclusion Criteria: * Clinically significant disease in any organ system * Positive urine drug screen