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

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ClinicalTrials.gov Identifier: NCT01941199
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( 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.

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2013
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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



Primary Outcome Measures :
  1. AUCτ,ss of DA-1229 and metformin [ Time Frame: up to 168h ]
  2. Cmax,ss of DA-1229 and metformin [ Time Frame: up to 168h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941199


Locations
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Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
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Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01941199    
Other Study ID Numbers: DA1229_DIM_I
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs