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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJanuary 27, 2021
January 1, 2021
Same day
March 26, 2009
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
24 hr
Secondary Outcomes (2)
Time of peak eletriptan concentrations (Tmax), half life
24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
3 weeks
Study Arms (5)
Eletriptan commercial tablet with water
ACTIVE COMPARATOREletriptan commercial tablet given with water
Eletriptan oral disintegrating tablet (ODT) #1 without water
EXPERIMENTALOral disintegrating tablet formulation #1 without water
Oral disintegrating tablet formulation (ODT) #2 without water
EXPERIMENTALOral disintegrating tablet formulation #2 without water
Oral disintegrating tablet formulation (ODT) #1 with water
EXPERIMENTALOral disintegrating tablet formulation (ODT) #1 with water
Oral disintegrating tablet formulation (ODT) #2 with water
EXPERIMENTALOral disintegrating tablet formulation (ODT) #2 with water
Interventions
40 mg tablet, given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
Eligibility Criteria
You may qualify if:
- Healthy subjects
- No CYP3A4 inhibitors
You may not qualify if:
- Clinically significant disease in any organ system
- Positive urine drug screen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
January 27, 2021
Record last verified: 2021-01