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

NCT03690778 | Completed Phase 1

• 1 other identifier: JLP-1310-104-PK
• Study Type: interventional
• Target: 42
• 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; Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• AUCt of Metformin and rosuvastatin

  48 hours

• Cmax of Metformin and rosuvastatin

  48 hours

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: "Metformin" and "Rosuvastatin" seperately; Drug: JLP-1310

Group II

EXPERIMENTAL

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

Drug: "Metformin" and "Rosuvastatin" seperately; Drug: JLP-1310

Interventions

"Metformin" and "Rosuvastatin" seperately DRUG

administration of "Metformin" and "Rosuvastatin" seperately

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 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.

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.
• 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.

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

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

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: September 27, 2018
• First Posted: October 1, 2018
• Study Start: October 4, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)