Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ODT #1 without water · 1 trial · 1 indication
| 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
ODT #1 without water is an investigational oral disintegrating tablet formulation developed by Pfizer, Inc. (ticker PFE). It is a small molecule drug candidate that has been studied in a Phase 1 clinical trial. The specific therapeutic indication for this formulation has not been disclosed.
ODT #1 without water is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating this oral disintegrating tablet formulation.
ODT #1 without water is in Phase 1 clinical development. It is an investigational drug candidate and is not approved by the FDA. The single Phase 1 trial for this formulation has been completed.
ODT #1 without water was evaluated in one completed Phase 1 trial, NCT00871806, titled Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water. The trial enrolled 20 healthy volunteers in Singapore and used an active-controlled, randomized design.
The Phase 1 trial NCT00871806 evaluated the pharmacokinetics of two eletriptan oral formulations, including one given without water, compared with the commercial tablet formulation given with water. The study enrolled 20 healthy volunteers of all sexes, aged 21 years and older, in Singapore, and it has been completed.