Teneligliptin and Atorvastatin DDI Study

• Status: Completed
• Trial end date: 2019-02-25
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium

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.