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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ODT #2 without water; Drug: Commercial tablet with water; Drug: ODT #2 with water; Drug: ODT #1 without water; Drug: ODT #1 with water

• Registration Number: NCT00871806
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-30
• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy subjects
• No CYP3A4 inhibitors

Exclusion Criteria

• Clinically significant disease in any organ system
• Positive urine drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral disintegrating tablet formulation (ODT) #2 without water	ODT #2 without water	Oral disintegrating tablet formulation #2 without water
Eletriptan commercial tablet with water	Commercial tablet with water	Eletriptan commercial tablet given with water
Oral disintegrating tablet formulation (ODT) #2 with water	ODT #2 with water	Oral disintegrating tablet formulation (ODT) #2 with water
Eletriptan oral disintegrating tablet (ODT) #1 without water	ODT #1 without water	Oral disintegrating tablet formulation #1 without water
Oral disintegrating tablet formulation (ODT) #1 with water	ODT #1 with water	Oral disintegrating tablet formulation (ODT) #1 with water

Primary Outcome Measures

Name	Time	Method
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)	24 hr

Secondary Outcome Measures

Name	Time	Method
Time of peak eletriptan concentrations (Tmax), half life	24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests	3 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore