Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.

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

Details

• Lead Sponsor: LG Life Sciences

Criteria

Inclusion Criteria:

• Male and female subjects who are able to understand and follow instructions during the study and available for study participation.

• Signed informed consent.

• White

Exclusion Criteria:

• Unwilling or unable to give informed consent.

• As a result of the medical screening process, a study physician considers the subject unfit for the study.

• The subject has a history of drug or other allergy which contraindicated study participation.

• Female subjects who are pregnant or lactating.

• Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise