CClinicalTrials.gg
CompletedNCT03690778Updated Mar 29, 2019

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

A Phase 1 interventional study of "Metformin" and "Rosuvastatin" seperately and JLP-1310 in Diabetes and Hyperlipidemias, sponsored by Jeil Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-29.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Diabetes
  • Hyperlipidemias

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 42 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Group I

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

    Drug: "Metformin" and "Rosuvastatin" seperately · Drug: JLP-1310

  • Experimental
    Group II

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

    Drug: "Metformin" and "Rosuvastatin" seperately · Drug: JLP-1310

Interventions

  • Drug"Metformin" and "Rosuvastatin" seperately

    administration of "Metformin" and "Rosuvastatin" seperately

  • DrugJLP-1310

    administration of JLP-1310

06

What researchers measure

Primary outcomes

  1. AUCt of Metformin and rosuvastatin

    Time frame: 48 hours

  2. Cmax of Metformin and rosuvastatin

    Time frame: 48 hours

07

Study locations

1 site
  • Inha University Hospital
    Incheon, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03690778
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2018
Start date
Oct 4, 2018
Primary completion
Feb 1, 2019
Completion
Feb 1, 2019
Last update
Mar 29, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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