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 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982798
• Other study ID #: JLP-1310-103-PK
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2016
• Last updated: March 28, 2018
• Start date: July 6, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: July 2017
• 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

Description:

A randomized, open-label, single dose, crossover clinical trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2018
• Est. primary completion date: August 30, 2017
• 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 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

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.

• 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.

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Metformin + Rosuvastatin
administration of Metformin + Rosuvastatin
• 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	AUClast of Metformin and rosuvastatin		48 hours
Primary	Cmax of Metformin and rosuvastatin		48 hours