An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pregabalin controlled release, 82.5 mg; Drug: Pregabalin immediate release, 150 mg; Drug: Pregabalin controlled release, 330 mg; Drug: Pregabalin controlled release, 165 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009541

A0081225

Details and patient eligibility

About

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Enrollment: 20 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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20 participants in 4 patient groups

Pregabalin controlled release, 82.5 mg

Experimental group

Treatment:

Drug: Pregabalin controlled release, 82.5 mg

Pregabalin controlled release, 165 mg

Experimental group

Treatment:

Drug: Pregabalin controlled release, 165 mg

Pregabalin controlled release, 330 mg

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg

Pregabalin immediate release, 150 mg

Other group

Description:

Reference Treatment

Treatment:

Drug: Pregabalin immediate release, 150 mg