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A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State

NCT03939143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-05-20

No results posted yet for this study

Summary

A study demonstrates the bioequivalence of DA-1229\_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults

Conditions

  • Type2 Diabetes

Interventions

DRUG

DA-1229_01(A), Sugamet SR Tab 5/1000mg®

Period 1: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.

DRUG

Sugamet SR Tab 5/1000mg®, DA-1229_01(A)

Period 1: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sung Dae Kwon, M.D., Ph.D. · Metro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2019-04-04
Completion
2019-04-04

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 NCT03939143 on ClinicalTrials.gov