MedDataX Logo

The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.

NCT ID: NCT03690778

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Hyperlipidemias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I

Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310

Group Type EXPERIMENTAL

"Metformin" and "Rosuvastatin" seperately

Intervention Type DRUG

administration of "Metformin" and "Rosuvastatin" seperately

JLP-1310

Intervention Type DRUG

administration of JLP-1310

Group II

Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately

Group Type EXPERIMENTAL

"Metformin" and "Rosuvastatin" seperately

Intervention Type DRUG

administration of "Metformin" and "Rosuvastatin" seperately

JLP-1310

Intervention Type DRUG

administration of JLP-1310

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"Metformin" and "Rosuvastatin" seperately

administration of "Metformin" and "Rosuvastatin" seperately

Intervention Type DRUG

JLP-1310

administration of JLP-1310

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male volunteer, age is over 19 years Body weight is over 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 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.

Exclusion Criteria

* 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.
* 100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
* AST or ALT \> X 2 UNL
* Total bilirubin \> 2.0 mg/dL
* CK \> X 2 UNL
* eGFR \< 60 mL/min/1.73m2
* 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.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inha University Hospital

Incheon, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JLP-1310-104-PK

Identifier Type: -

Identifier Source: org_study_id