- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982798
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers
March 28, 2018 updated by: Jeil Pharmaceutical Co., Ltd.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized, open-label, single dose, crossover clinical trial
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Incheon, Korea, Republic of
- Inha University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
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.
- Systolic BP > 140mmHG or Diastolic BP > 90mmHg)
- AST or ALT > X 2 UNL
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310
|
administration of Metformin + Rosuvastatin
administration of JLP-1310
|
Experimental: Group II
Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin
|
administration of Metformin + Rosuvastatin
administration of JLP-1310
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast of Metformin and rosuvastatin
Time Frame: 48 hours
|
48 hours
|
Cmax of Metformin and rosuvastatin
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2017
Primary Completion (Actual)
August 30, 2017
Study Completion (Actual)
January 31, 2018
Study Registration Dates
First Submitted
November 30, 2016
First Submitted That Met QC Criteria
December 1, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 28, 2018
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Metformin
Other Study ID Numbers
- JLP-1310-103-PK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on Metformin + Rosuvastatin
-
BC World Pharm Co. Ltd.CompletedHealthyKorea, Republic of
-
Jeil Pharmaceutical Co., Ltd.CompletedType 2 Diabetes | DyslipidemiaKorea, Republic of
-
Jeil Pharmaceutical Co., Ltd.CompletedDiabetes | HyperlipidemiaKorea, Republic of
-
Boehringer IngelheimCompleted
-
Yuhan CorporationCompleted
-
Jeil Pharmaceutical Co., Ltd.CompletedDiabetes | HyperlipidemiasKorea, Republic of
-
Yuhan CorporationCompletedPharmacokinetics and Drug Interaction of Crestor and Glucodown SRKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedDiabetes MellitusKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedDiabetes MellitusKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedDiabetes MellitusKorea, Republic of