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

NCT ID: NCT00871806

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Eletriptan commercial tablet with water

Eletriptan commercial tablet given with water

Group Type ACTIVE_COMPARATOR

Commercial tablet with water

Intervention Type DRUG

40 mg tablet, given once to each subject

Eletriptan oral disintegrating tablet (ODT) #1 without water

Oral disintegrating tablet formulation #1 without water

Group Type EXPERIMENTAL

ODT #1 without water

Intervention Type DRUG

40 mg tablet given once to each subject

Oral disintegrating tablet formulation (ODT) #2 without water

Oral disintegrating tablet formulation #2 without water

Group Type EXPERIMENTAL

ODT #2 without water

Intervention Type DRUG

40 mg tablet given once to each subject

Oral disintegrating tablet formulation (ODT) #1 with water

Oral disintegrating tablet formulation (ODT) #1 with water

Group Type EXPERIMENTAL

ODT #1 with water

Intervention Type DRUG

40 mg tablet given once to each subject

Oral disintegrating tablet formulation (ODT) #2 with water

Oral disintegrating tablet formulation (ODT) #2 with water

Group Type EXPERIMENTAL

ODT #2 with water

Intervention Type DRUG

40 mg tablet given once to each subject

Interventions

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Commercial tablet with water

40 mg tablet, given once to each subject

Intervention Type DRUG

ODT #1 without water

40 mg tablet given once to each subject

Intervention Type DRUG

ODT #2 without water

40 mg tablet given once to each subject

Intervention Type DRUG

ODT #1 with water

40 mg tablet given once to each subject

Intervention Type DRUG

ODT #2 with water

40 mg tablet given once to each subject

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* No CYP3A4 inhibitors

Exclusion Criteria

* Clinically significant disease in any organ system
* Positive urine drug screen
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

Other Identifiers

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A1601122

Identifier Type: -

Identifier Source: org_study_id

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