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Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults

NCT04972539 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-22

No results posted yet for this study

Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

AJU-A51 Tab.

Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet

DRUG

A51R1 Tab. and A51R2 Tab.

Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Sponsors & Collaborators

  • AJU Pharm Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jang Hee Hong · Chungnam National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2020-11-30
Completion
2021-03-09

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972539 on ClinicalTrials.gov