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Completed

NCT Number: NCT03769870

Teneligliptin and Atorvastatin DDI Study

A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea Universitiy Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male adult 19 to 45 years
  • Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
  • Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
  • Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Treatment and study plan

Teneligliptin 20mg/day

Drug

cross-over

Atorvastatin 40mg/Day

Drug

cross-over

Teneligliptin 20mg/day + Atorvastatin 40mg/day

Drug

cross-over

Primary outcomes

  1. Cmax,ss(Maximum concentration at steady state)

    Time frame: 24 hours

  2. AUCτ,ss(Area under the concentration-time curve at steady state)

    Time frame: 24hours

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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