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

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Type2 Diabetes

Treatments

Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride

Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02954822

DA1229_DIG_I

Details and patient eligibility

About

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

Full description

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

Enrollment

36 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 2 patient groups

(Group A)

Experimental group

Description:

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Treatment:

Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride

(Group B)

Experimental group

Description:

Glimepiride→Evogliptin→Evogliptin+Glimepiride

Treatment:

Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride

Trial contacts and locations

Data sourced from clinicaltrials.gov

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