Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone

Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone

Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin

Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02753803

DA1229_DIP_I

Details and patient eligibility

About

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Full description

A randomized, open-label, multiple-dose, three-treatment, three-period, six-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 6 patient groups

A group

Experimental group

Description:

Evogliptin Pioglitazone Evogliptin+Pioglitazone

Treatment:

Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

B group

Experimental group

Description:

Pioglitazone Evogliptin Evogliptin+Pioglitazone

Treatment:

Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone

C group

Experimental group

Description:

Evogliptin Evogliptin+Pioglitazone Pioglitazone

Treatment:

Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone

D group

Experimental group

Description:

Pioglitazone Evogliptin+Pioglitazone Evogliptin

Treatment:

Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin

E group

Experimental group

Description:

Evogliptin+Pioglitazone Evogliptin Pioglitazone

Treatment:

Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone

F group

Experimental group

Description:

Evogliptin+Pioglitazone Pioglitazone Evogliptin

Treatment:

Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

Trial contacts and locations

Data sourced from clinicaltrials.gov

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