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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02004587
Other study ID # LG-DPCL014
Secondary ID
Status Completed
Phase Phase 1
First received November 11, 2013
Last updated July 10, 2014
Start date September 2013
Est. completion date July 2014

Study information

Verified date July 2014
Source LG Life Sciences
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gemigliptin
Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.

Locations

Country Name City State
Germany CRS Clinical Research Services Kiel Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
LG Life Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC Blood samples will be prepared at planed points. Several time points until 72hr No
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