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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Type2 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03939143

DDS18-033BE

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Test drug, Reference drug group

Experimental group

Description:

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 fasting study is 14 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.

Treatment:

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

Reference drug,Test drug group

Active Comparator group

Description:

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 fasting study is 14 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.

Treatment:

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