Eletriptan Pharmacokinetics In Korean Males

NCT ID: NCT01139515

Last Updated: 2021-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-07-31

Brief Summary

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The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Detailed Description

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Conditions

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Healthy

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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Treatment A

1 X 20 mg eletriptan

Group Type EXPERIMENTAL

Eletriptan commercial tablet

Intervention Type DRUG

20 mg tablet, single dose

Treatment B

1 X 40 mg eletriptan

Group Type EXPERIMENTAL

Eletriptan commercial tablet

Intervention Type DRUG

40 mg tablet, single dose of 1 X 40 mg

Treatment C

2 X 40 mg eletriptan

Group Type EXPERIMENTAL

Eletriptan commercial tablet

Intervention Type DRUG

40 mg tablet, single dose of 2 X 40 mg

Treatment D

1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Group Type EXPERIMENTAL

Eletriptan commercial tablet

Intervention Type DRUG

40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

Interventions

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Eletriptan commercial tablet

20 mg tablet, single dose

Intervention Type DRUG

Eletriptan commercial tablet

40 mg tablet, single dose of 1 X 40 mg

Intervention Type DRUG

Eletriptan commercial tablet

40 mg tablet, single dose of 2 X 40 mg

Intervention Type DRUG

Eletriptan commercial tablet

40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male subjects, 18-55 years old
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
* provide informed consent

Exclusion Criteria

* blood pressure \>140/90 mm Hg
* any condition possibly affecting drug absorption
* positive urine drug screen
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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A1601126

Identifier Type: -

Identifier Source: org_study_id

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