Teneligliptin-Glimepiride DDI Study

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009513
• Other study ID #: MP_C103
• Status: Completed
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Teneligliptin+Glimepiride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)		24hr
Primary	Area under the plasma concentration versus time curve (AUC)		24hr