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

Phase 1

Completed

• Conditions: Hyperlipidemias; Diabetes
• Interventions: Drug: "Metformin" and "Rosuvastatin" seperately; Drug: JLP-1310

• Registration Number: NCT03690778
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-10-04
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	"Metformin" and "Rosuvastatin" seperately	Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Group II	"Metformin" and "Rosuvastatin" seperately	Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
Group I	JLP-1310	Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Group II	JLP-1310	Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately

Primary Outcome Measures

Name	Time	Method
Cmax of Metformin and rosuvastatin	48 hours
AUCt of Metformin and rosuvastatin	48 hours

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of