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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin

• Registration Number: NCT01941199
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D+M → D → M	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → M → D+M	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → D+M → M	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D → D+M	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D → D+M	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D+M → D	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D+M → D	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → M → D	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → M → D	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → D → M	DA-1229	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → M → D+M	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → D+M → M	DA-1229 + metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D → D+M	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → M → D+M	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D → D+M → M	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
M → D+M → D	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → M → D	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → D → M	metformin	D : DA-1229 5mg qd, M : metformin 1000mg bid

Primary Outcome Measures

Name	Time	Method
Cmax,ss of DA-1229 and metformin	up to 168h
AUCτ,ss of DA-1229 and metformin	up to 168h

Trial Locations

Locations (1)

Clinical Trial Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of