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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: DA-1229
Drug: metformin
Drug: DA-1229 + metformin
PhasePhase 1
SponsorDong-A Pharmaceutical Co., Ltd.
Responsible PartyDong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov IdentifierNCT01941199
First ReceivedSeptember 9, 2013
Last UpdatedNovember 25, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateSeptember 9, 2013
Last Updated DateNovember 25, 2013
Start DateJuly 2013
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measures
  • AUCτ,ss of DA-1229 and metformin [Time Frame: up to 168h] [Designated as safety issue: No]
  • Cmax,ss of DA-1229 and metformin [Time Frame: up to 168h] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
Official TitleA 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
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: DA-1229
Drug: metformin
Drug: DA-1229 + metformin
Study Arm (s)
  • Experimental: D → M → D+M
    D : DA-1229 5mg qd, M : metformin 1000mg bid
  • Experimental: D → D+M → M
    D : DA-1229 5mg qd, M : metformin 1000mg bid
  • Experimental: M → D → D+M
    D : DA-1229 5mg qd, M : metformin 1000mg bid
  • Experimental: M → D+M → D
    D : DA-1229 5mg qd, M : metformin 1000mg bid
  • Experimental: D+M → M → D
    D : DA-1229 5mg qd, M : metformin 1000mg bid
  • Experimental: D+M → D → M
    D : DA-1229 5mg qd, M : metformin 1000mg bid

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment36
Estimated Completion DateNot Provided
Estimated Primary Completion DateNovember 2013
Eligibility Criteria
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.
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01941199
Other Study ID NumbersDA1229_DIM_I
Has Data Monitoring CommitteeNot Provided
Information Provided ByDong-A Pharmaceutical Co., Ltd.
Study SponsorDong-A Pharmaceutical Co., Ltd.
CollaboratorsNot Provided
Investigators Not Provided
Verification DateNovember 2013

Locations[ + expand ][ + ]

Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744