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

Phase 1

Completed

• Conditions: Type2 Diabetes
• Interventions: Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin; Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin; Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin; Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

• Registration Number: NCT03766724
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-22
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Empagliflozin→Evogliptin→Evogliptin+Empagliflozin	Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
Group A	Evogliptin→Evogliptin+Empagliflozin→Empagliflozin	Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
Group D	Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin	Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
Group C	Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin	Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Primary Outcome Measures

Name	Time	Method
Cmax,ss	4 weeks	maximum serum concentration
AUCτ,ss	4 weeks	area under the concentration-time curve

Trial Locations

Locations (1)

Clinical Trials Center, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of