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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00871806
Enrollment
20
Registered
2009-03-30
Start date
2009-04-30
Completion date
2009-04-30
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics, eletriptan, bioavailability, oral disintegrating tablet

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.

Interventions

DRUGODT #1 without water

40 mg tablet given once to each subject

DRUGODT #2 without water

40 mg tablet given once to each subject

DRUGODT #1 with water

40 mg tablet given once to each subject

DRUGCommercial tablet with water

40 mg tablet, given once to each subject

DRUGODT #2 with water

40 mg tablet given once to each subject

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects * No CYP3A4 inhibitors

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)24 hr

Secondary

MeasureTime frame
Time of peak eletriptan concentrations (Tmax), half life24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests3 weeks

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026