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NCT02954822 Clinical Trial

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

Type2 Diabetes Clinical Trial

Official title:
A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02954822
Other study ID # DA1229_DIG_I
Secondary ID
Status Completed
Phase Phase 1
First received November 2, 2016
Last updated September 15, 2017
Start date November 14, 2016
Est. completion date August 9, 2017

Study information
Verified date September 2017
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 9, 2017
Est. primary completion date January 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• 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.

Locations
Country Name City State
Korea, Republic of Clinical Trials Center, Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt,ss for Evogliptin and Glimepiride area under the concentration-time curve 3 weeks
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