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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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	Healthy Volunteers
Intervention	Drug: Nateglinide Drug: Nateglinide/Metformin Drug: Metformin
Phase	Phase 1
Sponsor	IlDong Pharmaceutical Co Ltd
Responsible Party	IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier	NCT02088918
First Received	March 13, 2014
Last Updated	March 14, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 13, 2014
Last Updated Date	March 14, 2014
Start Date	October 2012
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	AUC last [Time Frame: 0-~24hrs] [Designated as safety issue: Yes] Cmax [Time Frame: 0~24hrs] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	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
Official Title	Not Provided
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy Volunteers
Intervention	Drug: Nateglinide Drug: Nateglinide/Metformin Drug: Metformin
Study Arm (s)	Active Comparator: Nateglinide+Metformin coadministration of nateglinide and metformin Experimental: Nateglinide/Metformin Nateglinide/Metformin tablet

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	December 2012
Eligibility Criteria	Inclusion Criteria: - Age between 20 and 40 - Signed informed consent Exclusion Criteria: - Has a history of hypersensitivity to IP ingredients - Hypertension or hyportension
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT02088918
Other Study ID Numbers	ID_Fasticmet_1201
Has Data Monitoring Committee	No
Information Provided By	IlDong Pharmaceutical Co Ltd
Study Sponsor	IlDong Pharmaceutical Co Ltd
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	March 2014

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