Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

• Status: Not yet recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Handok Inc.
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit

• Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit

• Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

Exclusion Criteria:

• History of type 1 diabetes mellitus and/or diabetic ketoacidosis

• Severe infection, surgery, or severe trauma within 6 months prior to the screening visit

• Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

• Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit

• Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study

• Subject determined by the principal investigator to be ineligible for study conduct for other reasons