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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: DA-1229; Drug: DA-1229 + metformin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01941199

DA1229_DIM_I

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

D → M → D+M

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin

D → D+M → M

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin

M → D → D+M

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin

M → D+M → D

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin

D+M → M → D

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin

D+M → D → M

Experimental group

Description:

D : DA-1229 5mg qd, M : metformin 1000mg bid

Treatment:

Drug: DA-1229

Drug: DA-1229 + metformin

Drug: metformin