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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03769870
Enrollment
30
Registered
2018-12-10
Start date
2019-01-11
Completion date
2019-02-25
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Mellitus

Brief summary

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

Interventions

DRUGTeneligliptin 20mg/day

cross-over

DRUGAtorvastatin 40mg/Day

cross-over

DRUGTeneligliptin 20mg/day + Atorvastatin 40mg/day

cross-over

Sponsors

Handok Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Cmax,ss(Maximum concentration at steady state)24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)24hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026