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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00871806
First received: March 26, 2009
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) [ Time Frame: 24 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of peak eletriptan concentrations (Tmax), half life [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
  • Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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: NCT00871806

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
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: NCT00871806     History of Changes
Other Study ID Numbers: A1601122
Study First Received: March 26, 2009
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacokinetics
eletriptan
bioavailability
oral disintegrating tablet

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

ClinicalTrials.gov processed this record on July 28, 2014