Teneligliptin and Atorvastatin DDI Study

NCT ID: NCT03769870

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2019-02-25

Brief Summary

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

Detailed Description

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Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Teneligliptin

Group Type OTHER

Teneligliptin 20mg/day

Intervention Type DRUG

cross-over

Atorvastatin

Group Type OTHER

Atorvastatin 40mg/Day

Intervention Type DRUG

cross-over

Teneligliptin + Atorvastatin

Group Type OTHER

Teneligliptin 20mg/day + Atorvastatin 40mg/day

Intervention Type DRUG

cross-over

Interventions

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Teneligliptin 20mg/day

cross-over

Intervention Type DRUG

Atorvastatin 40mg/Day

cross-over

Intervention Type DRUG

Teneligliptin 20mg/day + Atorvastatin 40mg/day

cross-over

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea Universitiy Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MP_C104

Identifier Type: -

Identifier Source: org_study_id

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