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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes; Hyperlipidemias

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03690778

JLP-1310-104-PK

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: JLP-1310

Drug: "Metformin" and "Rosuvastatin" seperately

Group II

Experimental group

Description:

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

Treatment:

Drug: JLP-1310

Drug: "Metformin" and "Rosuvastatin" seperately