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

NCT01941199 | Completed Phase 1

• 1 other identifier: DA1229_DIM_I
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss of DA-1229 and metformin

  up to 168h

• Cmax,ss of DA-1229 and metformin

  up to 168h

Study Arms (6)

D → M → D+M

EXPERIMENTAL

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

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

D → D+M → M

EXPERIMENTAL

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

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

M → D → D+M

EXPERIMENTAL

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

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

M → D+M → D

EXPERIMENTAL

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

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

D+M → M → D

EXPERIMENTAL

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

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

D+M → D → M

EXPERIMENTAL

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

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

Interventions

DA-1229 DRUG

D → D+M → M; D → M → D+M; D+M → D → M; D+M → M → D; M → D → D+M; M → D+M → D

metformin DRUG

D → D+M → M; D → M → D+M; D+M → D → M; D+M → M → D; M → D → D+M; M → D+M → D

DA-1229 + metformin DRUG

D → D+M → M; D → M → D+M; D+M → D → M; D+M → M → D; M → D → D+M; M → D+M → D

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 13, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

KR (1)