Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

Handok

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Teneligliptin and Empagliflozin; Drug: Teneligliptin; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04431141

MP-C105

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Teneligliptin

Experimental group

Treatment:

Drug: Teneligliptin

Empagliflozin

Experimental group

Treatment:

Drug: Empagliflozin

Teneligliptin and Empagliflozin

Experimental group

Treatment:

Drug: Teneligliptin and Empagliflozin