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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
Results First Received: June 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Intervention: Drug: Eletriptan commercial tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.

Participant Flow for 7 periods

 Period 1:   First Intervention Period
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout Period I (46hrs)
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 3:   Second Intervention Period
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 4:   Washout Period 2 (46 Hrs)
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 5:   Third Intervention Period
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 6:   Washout Period 3 (46 Hrs)
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 7:   Fourth Intervention Period
    Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose     Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg     Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  16  
Age  
[units: Years]
Mean ± Standard Deviation 		  24.8  ± 2.9  
Gender  
[units: Participants]
 		 
Female     0  
Male     16  



  Outcome Measures
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1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Primary:   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) ]
  Show Outcome Measure 2

3.  Primary:   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) ]
  Show Outcome Measure 3

4.  Secondary:   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) ]
  Show Outcome Measure 4

5.  Secondary:   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) ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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