NCT02449187

Brief Summary

A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Aug 2017

Typical duration for phase_1 diabetes

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

First Submitted

Initial submission to the registry

May 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 2, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

May 13, 2015

Last Update Submit

March 28, 2018

Conditions

DiabetesHyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Cmax

    48 hours from baseline

  • AUC(last)

    48 hours from baseline

Secondary Outcomes (5)

  • AUC(inf)

    48 hours from baseline

  • Tmax

    48 hours from baseline

  • T1/2

    48 hours from baseline

  • CL/F

    48 hours from baseline

  • Vd/F

    48 hours from baseline

Study Arms (2)

JLP-1310, Fasted followed by fed

EXPERIMENTAL

JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Drug: JLP-1310, Fasted followed by fed

JLP-1310, Fed followed by fasted

EXPERIMENTAL

JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Drug: JLP-1310, Fed followed by fasted

Interventions

JLP-1310, Fasted followed by fedDRUG

In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition.

Also known as: metformin hydrochloride, rosuvastatin calcium
JLP-1310, Fasted followed by fed
JLP-1310, Fed followed by fastedDRUG

In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition.

Also known as: metformin hydrochloride, rosuvastatin calcium
JLP-1310, Fed followed by fasted

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteer, age is over 19 years
  • Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Subject who has the ability and willingness to participate the whole period of trial

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
  • History of drug abuse or positive drug screening.
  • Participation in other drug studies within 3 months prior to the drug administration.
  • Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusHyperlipidemias

Interventions

MetforminRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sang Heon Cho, MD., Ph.D

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

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

May 13, 2015

First Posted

May 20, 2015

Study Start

August 2, 2017

Primary Completion

September 15, 2017

Study Completion

March 9, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)