Teneligliptin-Glimepiride DDI Study

NCT ID: NCT03009513

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-30

Brief Summary

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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Group Type: EXPERIMENTAL

Teneligliptin+Glimepiride

Intervention Type: DRUG

Interventions

Teneligliptin+Glimepiride

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Handok Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MP_C103

Identifier Type: -

Identifier Source: org_study_id