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Eletriptan Pharmacokinetics In Korean Males

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01139515
First received: June 7, 2010
Last updated: June 13, 2011
Last verified: June 2011
History of Changes

June 7, 2010
June 13, 2011
July 2010
July 2010   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • AUCinf of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cmax of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01139515 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Tmax of eletriptan [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01139515
A1601126
No
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