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A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02088918
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Nateglinide Drug: Nateglinide/Metformin Drug: Metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nateglinide+Metformin
coadministration of nateglinide and metformin
Drug: Nateglinide
Drug: Metformin
Experimental: Nateglinide/Metformin
Nateglinide/Metformin tablet
Drug: Nateglinide/Metformin



Primary Outcome Measures :
  1. AUC last [ Time Frame: 0-~24hrs ]
  2. Cmax [ Time Frame: 0~24hrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 and 40
  • Signed informed consent

Exclusion Criteria:

  • Has a history of hypersensitivity to IP ingredients
  • Hypertension or hyportension

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): NCT02088918


Locations
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Korea, Republic of
Chungnam University Hospital
Daejeon, Korea, Republic of
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02088918    
Other Study ID Numbers: ID_Fasticmet_1201
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Metformin
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs