MedDataX Logo

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

NCT ID: NCT02954822

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2017-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

(Group A)

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Group Type EXPERIMENTAL

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Intervention Type DRUG

Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.

Glimepiride : Glimepiride 4mg QD

Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

(Group B)

Glimepiride→Evogliptin→Evogliptin+Glimepiride

Group Type EXPERIMENTAL

Glimepiride→Evogliptin→Evogliptin+Glimepiride

Intervention Type DRUG

After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.

Glimepiride : Glimepiride 4mg QD

Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

Intervention Type DRUG

Glimepiride→Evogliptin→Evogliptin+Glimepiride

After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Suganon, Amaryl Suganon, Amaryl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy Male Volunteers (Age: 19\~45years)
* 55\<Body Weight\<90, 18\<BMI\<27
* FPG: 70-125 mg/dL

Exclusion Criteria

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Clinically significant Medical History
* Allergy or Drug Hypersensitivity
* AST(SGOT), ALT(SGPT) \> Upper Normal Range\*1.5, eGFR\<80 mL/min
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kyung-Sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DA1229_DIG_I

Identifier Type: -

Identifier Source: org_study_id