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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eletriptan commercial tablet with water
Eletriptan commercial tablet given with water
Drug: Commercial tablet with water
40 mg tablet, given once to each subject
Experimental: Eletriptan oral disintegrating tablet (ODT) #1 without water
Oral disintegrating tablet formulation #1 without water
Drug: ODT #1 without water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 without water
Oral disintegrating tablet formulation #2 without water
Drug: ODT #2 without water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #1 with water
Drug: ODT #1 with water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 with water
Drug: ODT #2 with water
40 mg tablet given once to each subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
Time Frame: 24 hr
24 hr

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A1601122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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