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NCT03769870 Clinical Trial

Teneligliptin and Atorvastatin DDI Study

Diabete Mellitus Clinical Trial

Official title:
A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03769870
Other study ID # MP_C104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 11, 2019
Est. completion date February 25, 2019

Study information
Verified date May 2019
Source Handok Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 25, 2019
Est. primary completion date February 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

1. Healthy male adult 19 to 45 years

2. Body weight = 50kg, and BMI between 18-29kg/m2 at screening

3. Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.

4. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Teneligliptin 20mg/day
cross-over
• Atorvastatin 40mg/Day
cross-over
• Teneligliptin 20mg/day + Atorvastatin 40mg/day
cross-over

Locations
Country Name City State
Korea, Republic of Korea Universitiy Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss(Maximum concentration at steady state) 24 hours
Primary AUCt,ss(Area under the concentration-time curve at steady state) 24hours
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