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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Commercial tablet with water; Drug: ODT #1 with water; Drug: ODT #2 with water; Drug: ODT #1 without 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)

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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