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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02088918

Enrollment

Registered

2014-03-17

Start date

2012-10-31

Completion date

Unknown

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

DRUGNateglinide

DRUGNateglinide/Metformin

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
AUC last	0-~24hrs
Cmax	0~24hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026