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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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Eletriptan commercial tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: July 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
1 X 20 mg eletriptan
Drug: Eletriptan commercial tablet
20 mg tablet, single dose
Experimental: Treatment B
1 X 40 mg eletriptan
Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 1 X 40 mg
Experimental: Treatment C
2 X 40 mg eletriptan
Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 2 X 40 mg
Experimental: Treatment D
1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose
Drug: Eletriptan commercial tablet
40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139515

Locations
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01139515     History of Changes
Other Study ID Numbers: A1601126
Study First Received: June 7, 2010
Results First Received: June 13, 2011
Last Updated: June 13, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetic
eletriptan
Korean
crossover

Additional relevant MeSH terms:
Eletriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on November 20, 2014