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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03690778

Recruitment Status : Completed

First Posted : October 1, 2018

Last Update Posted : March 29, 2019

Sponsor:

Information provided by (Responsible Party):

Jeil Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Hyperlipidemias	Drug: "Metformin" and "Rosuvastatin" seperately Drug: JLP-1310	Phase 1

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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 (1000/10mg) in Healthy Male Volunteers.
Actual Study Start Date :	October 4, 2018
Actual Primary Completion Date :	February 1, 2019
Actual Study Completion Date :	February 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin Metformin hydrochloride Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group I Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310	Drug: "Metformin" and "Rosuvastatin" seperately administration of "Metformin" and "Rosuvastatin" seperately Drug: JLP-1310 administration of JLP-1310
Experimental: Group II Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately	Drug: "Metformin" and "Rosuvastatin" seperately administration of "Metformin" and "Rosuvastatin" seperately Drug: JLP-1310 administration of JLP-1310

Outcome Measures

Primary Outcome Measures :

AUCt of Metformin and rosuvastatin [ Time Frame: 48 hours ]
Cmax of Metformin and rosuvastatin [ Time Frame: 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690778

Locations

Layout table for location information

Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of

Sponsors and Collaborators

Jeil Pharmaceutical Co., Ltd.

More Information

Layout table for additonal information

Responsible Party:	Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT03690778
Other Study ID Numbers:	JLP-1310-104-PK
First Posted:	October 1, 2018 Key Record Dates
Last Update Posted:	March 29, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Metformin Rosuvastatin Calcium Hypoglycemic Agents Physiological Effects of Drugs	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

To Top