NCT02088918

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 13, 2014

Last Update Submit

March 14, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • AUC last

    0-~24hrs

  • Cmax

    0~24hrs

Study Arms (2)

Nateglinide+Metformin

ACTIVE COMPARATOR

coadministration of nateglinide and metformin

Drug: NateglinideDrug: Metformin

Nateglinide/Metformin

EXPERIMENTAL

Nateglinide/Metformin tablet

Drug: Nateglinide/Metformin

Interventions

NateglinideDRUG
Nateglinide+Metformin
Nateglinide/MetforminDRUG
Nateglinide/Metformin
MetforminDRUG
Nateglinide+Metformin

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 40
  • Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam University Hospital

Daejeon, South Korea

Location

MeSH Terms

Interventions

NateglinideMetformin

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

KR(1)