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Teneligliptin and Atorvastatin DDI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769870
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Handok Inc.

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

Condition or disease Intervention/treatment Phase
Diabete Mellitus Drug: Teneligliptin 20mg/day Drug: Atorvastatin 40mg/Day Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults
Actual Study Start Date : January 11, 2019
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Teneligliptin Drug: Teneligliptin 20mg/day
cross-over

Atorvastatin Drug: Atorvastatin 40mg/Day
cross-over

Teneligliptin + Atorvastatin Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day
cross-over




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male adult 19 to 45 years
  2. Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
  3. 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.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769870


Locations
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Korea, Republic of
Korea Universitiy Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Inc.

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Responsible Party: Handok Inc.
ClinicalTrials.gov Identifier: NCT03769870     History of Changes
Other Study ID Numbers: MP_C104
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors