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

D

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

1

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Data sourced from clinicaltrials.gov

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