An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: erythromycin; Drug: Pregabalin controlled release, 330 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342198

A0081197

Details and patient eligibility

About

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.

Full description

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or females
• Between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion criteria

• Illicit drug use
• Pregnant or nursing females
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

1

Experimental group

Description:

Single Dose Pregabalin Controlled Release

Treatment:

Drug: Pregabalin controlled release, 330 mg

Drug: Pregabalin controlled release, 330 mg

2

Experimental group

Description:

Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin

Treatment:

Drug: Pregabalin controlled release, 330 mg

Drug: erythromycin

Drug: Pregabalin controlled release, 330 mg