NCT00871806

Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Commercial tablet with water	40 mg tablet, given once to each subject
DRUG	ODT #1 without water	40 mg tablet given once to each subject
DRUG	ODT #2 without water	40 mg tablet given once to each subject
DRUG	ODT #1 with water	40 mg tablet given once to each subject
DRUG	ODT #2 with water	40 mg tablet given once to each subject

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-03-30
• Last updated: 2021-01-27

Locations

1 site across 1 country: Singapore