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

Dong-A ST Co., Ltd.34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Type2 Diabetes

Interventions

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

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.

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

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.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients over 19 years of age at the time of health examination * Female patients who were confirmed to be not pregnant at health examination * Patients without a history of mental illness in the past 5 years Exclusion Criteria: * Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial * Patients with a congestive heart failure which requires medicinal treatment * Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial * Female patients who are lactating

Locations (1)

Metro Hospital

Anyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Area under the concentration-time curve(AUCt)

AUCt of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Maximum plasmaconcentration of drug in plasma(Cmax)

Cmax of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Secondary Outcomes

Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)

AUCinf of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

AUCt/AUCinf

AUCt/AUCinf of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Time to reach the maximum plasma concentration(Tmax)

Tmax of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Terminal elimination rate constant(ramda z)

ramda z of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Terminal elimination half-life(t1/2)

t1/2 of evogliptin and metformin

Time frame: Hour -1 ~ Hour 72

Data from ClinicalTrials.gov

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