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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03690778

Enrollment

Registered

2018-10-01

Start date

2018-10-04

Completion date

2019-02-01

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperlipidemias

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.

Interventions

DRUGMetformin and Rosuvastatin seperately

administration of Metformin and Rosuvastatin seperately

DRUGJLP-1310

administration of JLP-1310

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUCt of Metformin and rosuvastatin	48 hours
Cmax of Metformin and rosuvastatin	48 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026