Status:
COMPLETED
Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin
Lead Sponsor:
Handok Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04431141
Start Date
September 15 2020
End Date
January 25 2021
Last Update
November 15 2021
Active Locations (1)
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1
Clinical Pharmacology, Asan Medical Center
Seoul, South Korea