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

Randomized, Open Label, Single Oral Administration at Fed State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)

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

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®; Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Anyang si, Gyeonggi-do, Korea, Republic of, 14096
      • Metro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test drug, Reference drug group; Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.	Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®; Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.; Other Names: Test drug, Reference drug group
ACTIVE_COMPARATOR: Reference drug,Test drug group; Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) 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(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.; Other Names: Reference drug,Test drug group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve(AUCt)	AUCt of metformin	Hour -1 ~ Hour 24
Maximum plasmaconcentration of drug in plasma(Cmax)	Cmax of metformin	Hour -1 ~ Hour 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)	AUCinf of metformin	Hour -1 ~ Hour 24
AUCt/AUCinf	AUCt/AUCinf of metformin	Hour -1 ~ Hour 24
Time to reach the maximum plasma concentration(Tmax)	Tmax of metformin	Hour -1 ~ Hour 24
Terminal elimination rate constant(ramda z)	ramda z of metformin	Hour -1 ~ Hour 24
Terminal elimination half-life(t1/2)	t1/2 of metformin	Hour -1 ~ Hour 24

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Sung Dae Kwon, M.D., Ph.D., Metro Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2019
• Primary Completion (ACTUAL): March 25, 2019
• Study Completion (ACTUAL): March 25, 2019

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DDS18-034BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No