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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766724
• Other study ID #: DA1229_DIS_I
• Status: Completed
• Phase: Phase 1
• Start date: November 22, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: April 2019
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Type2 Diabetes

Intervention

Drug:
• Evogliptin?Evogliptin+Empagliflozin?Empagliflozin
Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD
• Empagliflozin?Evogliptin?Evogliptin+Empagliflozin
Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD
• Evogliptin?Evogliptin+Dapagliflozin?Dapagliflozin
Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD
• Dapagliflozin?Evogliptin?Evogliptin+Dapagliflozin
Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt,ss	area under the concentration-time curve	4 weeks
Primary	Cmax,ss	maximum serum concentration	4 weeks