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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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NCT00871806

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects

- No CYP3A4 inhibitors

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically significant disease in any organ system

- Positive urine drug screen

NCT00871806
Pfizer
Completed
Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

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Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion Criteria:

  • Clinically significant disease in any organ system
  • Positive urine drug screen
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00871806
A1601122
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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