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

• Sponsor: IlDong Pharmaceutical Co Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02088918
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUC last [0-~24hrs]

2. Cmax [0~24hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age between 20 and 40

• Signed informed consent

Exclusion Criteria:

• Has a history of hypersensitivity to IP ingredients

• Hypertension or hyportension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam University Hospital	Daejeon		Korea, Republic of

Sponsors and Collaborators

• IlDong Pharmaceutical Co Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IlDong Pharmaceutical Co Ltd
• ClinicalTrials.gov Identifier: NCT02088918
• Other Study ID Numbers: ID_Fasticmet_1201
• First Posted: Mar 17, 2014
• Last Update Posted: Mar 17, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Metformin; Nateglinide

Study Results

No Results Posted as of Mar 17, 2014