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OpenTrials
Completed

NCT Number: NCT00871806

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

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Key information

Conditions

Healthy Volunteers

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion criteria

  • Clinically significant disease in any organ system
  • Positive urine drug screen

Treatment and study plan

Commercial tablet with water

Drug

40 mg tablet, given once to each subject

ODT #1 without water

Drug

40 mg tablet given once to each subject

ODT #2 without water

Drug

40 mg tablet given once to each subject

ODT #1 with water

Drug

40 mg tablet given once to each subject

ODT #2 with water

Drug

40 mg tablet given once to each subject

Primary outcomes

  1. Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)

    Time frame: 24 hr

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2009
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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