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NCT00871806 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00871806
Other study ID # A1601122
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2009
Est. completion date April 2009

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy subjects - No CYP3A4 inhibitors Exclusion Criteria: - Clinically significant disease in any organ system - Positive urine drug screen

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Commercial tablet with water
40 mg tablet, given once to each subject
• ODT #1 without water
40 mg tablet given once to each subject
• ODT #2 without water
40 mg tablet given once to each subject
• ODT #1 with water
40 mg tablet given once to each subject
• ODT #2 with water
40 mg tablet given once to each subject

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) 24 hr
Secondary Time of peak eletriptan concentrations (Tmax), half life 24 hr
Secondary Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests 3 weeks
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