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

NCT03944200 | Completed Phase 1

• 1 other identifier: DDS18-034BE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

  Hour -1 ~ Hour 24

• AUCt/AUCinf

  Hour -1 ~ Hour 24

• Time to reach the maximum plasma concentration(Tmax)

  Hour -1 ~ Hour 24

• Terminal elimination rate constant(ramda z)

  Hour -1 ~ Hour 24

• Terminal elimination half-life(t1/2)

  Hour -1 ~ Hour 24

Study Arms (2)

Test drug, Reference drug group

EXPERIMENTAL

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®

Reference drug,Test drug group

ACTIVE COMPARATOR

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)

Interventions

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

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.

Also known as: Test drug, Reference drug group

Test drug, Reference drug group

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

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.

Also known as: Reference drug,Test drug group

Reference drug,Test drug group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Metro Hospital

Anyang-si, Gyeonggi-do, 14096, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Sung Dae Kwon, M.D., Ph.D.

  Metro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: May 9, 2019
• Study Start: February 7, 2019
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: May 20, 2020

Record last verified: 2019-05

Locations

KR (1)