Teneligliptin and Atorvastatin DDI Study

Handok

Status and phase: Completed; Phase 1

Conditions: Diabete Mellitus

Treatments: Drug: Atorvastatin 40mg/Day; Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day; Drug: Teneligliptin 20mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT03769870

MP_C104

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Teneligliptin

Other group

Treatment:

Drug: Teneligliptin 20mg/day

Atorvastatin

Other group

Treatment:

Drug: Atorvastatin 40mg/Day

Teneligliptin + Atorvastatin

Other group

Treatment:

Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day