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Eletriptan Pharmacokinetics In Korean Males

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NCT01139515

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seoul, , 110-744 Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy male subjects, 18-55 years old

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

- provide informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- blood pressure >140/90 mm Hg

- any condition possibly affecting drug absorption

- positive urine drug screen

NCT01139515
Pfizer
Completed
Eletriptan Pharmacokinetics In Korean Males

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Eletriptan Pharmacokinetics In Korean Males
An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Eletriptan commercial tablet
    20 mg tablet, single dose
  • Drug: Eletriptan commercial tablet
    40 mg tablet, single dose of 1 X 40 mg
  • Drug: Eletriptan commercial tablet
    40 mg tablet, single dose of 2 X 40 mg
  • Drug: Eletriptan commercial tablet
    40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first
  • Experimental: Treatment A
    1 X 20 mg eletriptan
    Intervention: Drug: Eletriptan commercial tablet
  • Experimental: Treatment B
    1 X 40 mg eletriptan
    Intervention: Drug: Eletriptan commercial tablet
  • Experimental: Treatment C
    2 X 40 mg eletriptan
    Intervention: Drug: Eletriptan commercial tablet
  • Experimental: Treatment D
    1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose
    Intervention: Drug: Eletriptan commercial tablet
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01139515
A1601126
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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