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

Diabetes Clinical Trial

Official title:

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 (1000/10mg) in Healthy Male Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690778
• Other study ID #: JLP-1310-104-PK
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2019
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• "Metformin" and "Rosuvastatin" seperately
administration of "Metformin" and "Rosuvastatin" seperately
• JLP-1310
administration of JLP-1310

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Metformin and rosuvastatin		48 hours
Primary	Cmax of Metformin and rosuvastatin		48 hours