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Trial record 1 of 1 for:    NCT01139515
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Eletriptan Pharmacokinetics In Korean Males

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ClinicalTrials.gov Identifier: NCT01139515
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 7, 2010
First Posted Date  ICMJE June 8, 2010
Results First Submitted Date  ICMJE June 13, 2011
Results First Posted Date  ICMJE July 12, 2011
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [ Time Frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D) ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
  • AUC From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) ]
    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
  • AUC(0-last) of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • AUCinf of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • Cmax of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) ]
  • Plasma Decay Half Life (t1/2) [ Time Frame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
  • Tmax of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • half life of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • safety laboratory tests, vital signs, and adverse events [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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