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

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Viatris

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ODT #1 with water
Drug: Commercial tablet with water
Drug: ODT #1 without water
Drug: ODT #2 with water
Drug: ODT #2 without water

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871806
A1601122

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy subjects
  • No CYP3A4 inhibitors

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 5 patient groups

Eletriptan commercial tablet with water
Active Comparator group
Description:
Eletriptan commercial tablet given with water
Treatment:
Drug: Commercial tablet with water
Eletriptan oral disintegrating tablet (ODT) #1 without water
Experimental group
Description:
Oral disintegrating tablet formulation #1 without water
Treatment:
Drug: ODT #1 without water
Oral disintegrating tablet formulation (ODT) #2 without water
Experimental group
Description:
Oral disintegrating tablet formulation #2 without water
Treatment:
Drug: ODT #2 without water
Oral disintegrating tablet formulation (ODT) #1 with water
Experimental group
Description:
Oral disintegrating tablet formulation (ODT) #1 with water
Treatment:
Drug: ODT #1 with water
Oral disintegrating tablet formulation (ODT) #2 with water
Experimental group
Description:
Oral disintegrating tablet formulation (ODT) #2 with water
Treatment:
Drug: ODT #2 with water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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