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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Nateglinide/Metformin; Drug: Nateglinide; Drug: Metformin

• Registration Number: NCT02088918
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-14
• Last Update Submitted: 2014-03-14
• Study First Posted: 2014-03-17
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age between 20 and 40
• Signed informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nateglinide/Metformin	Nateglinide/Metformin	Nateglinide/Metformin tablet
Nateglinide+Metformin	Metformin	coadministration of nateglinide and metformin
Nateglinide+Metformin	Nateglinide	coadministration of nateglinide and metformin

Primary Outcome Measures

Name	Time	Method
AUC last	0-~24hrs
Cmax	0~24hrs

Trial Locations

Locations (1)

Chungnam University Hospital; 🇰🇷 Daejeon, Korea, Republic of