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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944200
• Other study ID #: DDS18-034BE
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2019
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2019
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Metro Hospital	Anyang si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve(AUCt)	AUCt of metformin	Hour -1 ~ Hour 24
Primary	Maximum plasmaconcentration of drug in plasma(Cmax)	Cmax of metformin	Hour -1 ~ Hour 24
Secondary	Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)	AUCinf of metformin	Hour -1 ~ Hour 24
Secondary	AUCt/AUCinf	AUCt/AUCinf of metformin	Hour -1 ~ Hour 24
Secondary	Time to reach the maximum plasma concentration(Tmax)	Tmax of metformin	Hour -1 ~ Hour 24
Secondary	Terminal elimination rate constant(ramda z)	ramda z of metformin	Hour -1 ~ Hour 24
Secondary	Terminal elimination half-life(t1/2)	t1/2 of metformin	Hour -1 ~ Hour 24