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Trial record 1 of 1 for:    NCT00871806
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Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

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ClinicalTrials.gov Identifier: NCT00871806
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : April 23, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 26, 2009
First Posted Date  ICMJE March 30, 2009
Last Update Posted Date April 23, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) [ Time Frame: 24 hr ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
  • Time of peak eletriptan concentrations (Tmax), half life [ Time Frame: 24 hr ]
  • Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
Brief Summary The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
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 Volunteers
Intervention  ICMJE
  • Drug: Commercial tablet with water
    40 mg tablet, given once to each subject
  • Drug: ODT #1 without water
    40 mg tablet given once to each subject
  • Drug: ODT #2 without water
    40 mg tablet given once to each subject
  • Drug: ODT #1 with water
    40 mg tablet given once to each subject
  • Drug: ODT #2 with water
    40 mg tablet given once to each subject
Study Arms  ICMJE
  • Active Comparator: Eletriptan commercial tablet with water
    Eletriptan commercial tablet given with water
    Intervention: Drug: Commercial tablet with water
  • Experimental: Eletriptan oral disintegrating tablet (ODT) #1 without water
    Oral disintegrating tablet formulation #1 without water
    Intervention: Drug: ODT #1 without water
  • Experimental: Oral disintegrating tablet formulation (ODT) #2 without water
    Oral disintegrating tablet formulation #2 without water
    Intervention: Drug: ODT #2 without water
  • Experimental: Oral disintegrating tablet formulation (ODT) #1 with water
    Oral disintegrating tablet formulation (ODT) #1 with water
    Intervention: Drug: ODT #1 with water
  • Experimental: Oral disintegrating tablet formulation (ODT) #2 with water
    Oral disintegrating tablet formulation (ODT) #2 with water
    Intervention: Drug: ODT #2 with water
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: March 26, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion Criteria:

  • Clinically significant disease in any organ system
  • Positive urine drug screen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00871806
Other Study ID Numbers  ICMJE A1601122
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 April 2010

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