NCT02088918
Completed
Phase 1
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
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Nateglinide
- Conditions
- Healthy Volunteers
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- AUC last
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
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
Arms & Interventions
Nateglinide+Metformin
coadministration of nateglinide and metformin
Intervention: Nateglinide
Nateglinide+Metformin
coadministration of nateglinide and metformin
Intervention: Metformin
Nateglinide/Metformin
Nateglinide/Metformin tablet
Intervention: Nateglinide/Metformin
Outcomes
Primary Outcomes
AUC last
Time Frame: 0-~24hrs
Cmax
Time Frame: 0~24hrs
Study Sites (1)
Loading locations...
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