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

IlDong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Nateglinide; Drug: Metformin; Drug: Nateglinide/Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02088918

ID_Fasticmet_1201

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20 and 40
• Signed informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Nateglinide+Metformin

Active Comparator group

Description:

coadministration of nateglinide and metformin

Treatment:

Drug: Nateglinide

Drug: Metformin

Nateglinide/Metformin

Experimental group

Description:

Nateglinide/Metformin tablet

Treatment:

Drug: Nateglinide/Metformin