Teneligliptin-Glimepiride DDI Study

Handok

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Teneligliptin+Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03009513

MP_C103

Details and patient eligibility

About

An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects

Enrollment: 26 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy male adult aged 20 to 45 years
2. Body weight ≥ 50kg, and BMI between 18 and 29 kg/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.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

single arm

Experimental group

Treatment:

Drug: Teneligliptin+Glimepiride