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OpenTrials
Completed

NCT Number: NCT03690778

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 in healthy male volunteers.

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Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hospital

Incheon, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"Metformin" and "Rosuvastatin" seperately

Drug

administration of "Metformin" and "Rosuvastatin" seperately

JLP-1310

Drug

administration of JLP-1310

Primary outcomes

  1. AUCt of Metformin and rosuvastatin

    Time frame: 48 hours

  2. Cmax of Metformin and rosuvastatin

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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