Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Type2 Diabetes

Treatments: Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin; Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin; Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin; Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03766724

DA1229_DIS_I

Details and patient eligibility

About

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Enrollment: 42 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health Male Volunteers (Age : 19~55 years)
• Body Weight≥55kg, 18.5≤BMI<25.0

Exclusion criteria

• galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Allergy or Drug hypersensitivity
• Clinically significant Medical History
• AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73㎡
• 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)

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42 participants in 4 patient groups

Group A

Experimental group

Description:

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Treatment:

Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Group B

Experimental group

Description:

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Treatment:

Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Group C

Experimental group

Description:

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Treatment:

Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Group D

Experimental group

Description:

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Treatment:

Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin