PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2

• Who has not suffered from clinically significant disease

• Provision of signed written informed consent

Exclusion Criteria:

• History of and clinically significant disease

• A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs

• Administration of other investigational products within 3 months prior to the first dosing