Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

Sponsor

Dong-A Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01941199

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D → M → D+M D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin
Experimental: D → D+M → M D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin
Experimental: M → D → D+M D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin
Experimental: M → D+M → D D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin
Experimental: D+M → M → D D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin
Experimental: D+M → D → M D : DA-1229 5mg qd, M : metformin 1000mg bid	Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin

Outcome Measures

Primary Outcome Measures

AUCτ,ss of DA-1229 and metformin [up to 168h]
Cmax,ss of DA-1229 and metformin [up to 168h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 20 to 45, healthy male subjects(at screening)
Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
FPG 70-125mg/dL glucose level(at screening)
Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction
Subject who already participated in other trials in 2 months
Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Center, Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong-A Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01941199

Other Study ID Numbers:

DA1229_DIM_I

First Posted:

Sep 13, 2013

Last Update Posted:

Nov 27, 2013

Last Verified:

Nov 1, 2013

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Metformin

Study Results

No Results Posted as of Nov 27, 2013