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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT00871806 |
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Date of registration:
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26/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00871806 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy subjects
- No CYP3A4 inhibitors
Exclusion Criteria:
- Clinically significant disease in any organ system
- Positive urine drug screen
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Commercial tablet with water
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Drug: ODT #1 without water
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Drug: ODT #1 with water
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Drug: ODT #2 with water
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Drug: ODT #2 without water
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Primary Outcome(s)
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Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
[Time Frame: 24 hr]
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Secondary Outcome(s)
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Time of peak eletriptan concentrations (Tmax), half life
[Time Frame: 24 hr]
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Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
[Time Frame: 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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