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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00871806
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Commercial tablet with water Drug: ODT #1 without water Drug: ODT #2 without water Drug: ODT #1 with water Drug: ODT #2 with water Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
Drug Information available for: Eletriptan

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Eletriptan commercial tablet with water
Eletriptan commercial tablet given with water
 Drug: Commercial tablet with water
40 mg tablet, given once to each subject
Experimental: Eletriptan oral disintegrating tablet (ODT) #1 without water
Oral disintegrating tablet formulation #1 without water
 Drug: ODT #1 without water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 without water
Oral disintegrating tablet formulation #2 without water
 Drug: ODT #2 without water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #1 with water
Oral disintegrating tablet formulation (ODT) #1 with water
 Drug: ODT #1 with water
40 mg tablet given once to each subject
Experimental: Oral disintegrating tablet formulation (ODT) #2 with water
Oral disintegrating tablet formulation (ODT) #2 with water
 Drug: ODT #2 with water
40 mg tablet given once to each subject


Outcome Measures
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Primary Outcome Measures :
  1. Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) [ Time Frame: 24 hr ]

Secondary Outcome Measures :
  1. Time of peak eletriptan concentrations (Tmax), half life [ Time Frame: 24 hr ]
  2. Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests [ Time Frame: 3 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion Criteria:

  • Clinically significant disease in any organ system
  • Positive urine drug screen
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871806


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00871806    
Other Study ID Numbers: A1601122
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Keywords provided by Pfizer:
Pharmacokinetics
eletriptan
bioavailability
oral disintegrating tablet