Eletriptan Pharmacokinetics In Korean Males

NCT01139515

Last updated date
Study Location
Pfizer Investigational Site
Seoul, , 110-744, Korea, Republic of
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Eletriptan Pharmacokinetics In Korean Males
Official Title  ICMJE 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
Brief Summary The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2010)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01139515
Other Study ID Numbers  ICMJE A1601126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP