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

NCT02982798 | Completed Phase 1

• 1 other identifier: JLP-1310-103-PK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• AUClast of Metformin and rosuvastatin

  48 hours

• Cmax of Metformin and rosuvastatin

  48 hours

Study Arms (2)

Group I

EXPERIMENTAL

Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310

Drug: Metformin + Rosuvastatin; Drug: JLP-1310

Group II

EXPERIMENTAL

Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin

Drug: Metformin + Rosuvastatin; Drug: JLP-1310

Interventions

Metformin + Rosuvastatin DRUG

administration of Metformin + Rosuvastatin

Group I; Group II

JLP-1310 DRUG

administration of JLP-1310

Group I; Group II

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperlipidemias

Interventions

Metformin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: November 30, 2016
• First Posted: December 5, 2016
• Study Start: July 6, 2017
• Primary Completion: August 30, 2017
• Study Completion: January 31, 2018
• Last Updated: March 29, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)