Eletriptan Pharmacokinetics In Korean Males

Viatris

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Eletriptan commercial tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01139515

A1601126

Details and patient eligibility

About

The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Enrollment

16 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy male subjects, 18-55 years old
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
provide informed consent

Exclusion criteria

blood pressure >140/90 mm Hg
any condition possibly affecting drug absorption
positive urine drug screen

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 4 patient groups

Treatment A

Experimental group

Description:

1 X 20 mg eletriptan

Treatment:

Drug: Eletriptan commercial tablet

Treatment B

Experimental group

Description:

1 X 40 mg eletriptan

Treatment:

Drug: Eletriptan commercial tablet

Treatment C

Experimental group

Description:

2 X 40 mg eletriptan

Treatment:

Drug: Eletriptan commercial tablet

Treatment D

Experimental group

Description:

1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Treatment:

Drug: Eletriptan commercial tablet

Trial contacts and locations

1

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