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

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Jeil Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Diabetes
Hyperlipidemia

Treatments

Drug: JLP-1310
Drug: Metformin + Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02982798
JLP-1310-103-PK

Details and patient eligibility

About

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

Full description

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

Enrollment

40 patients

Sex

Male

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Group I
Experimental group
Description:
Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310
Treatment:
Drug: Metformin + Rosuvastatin
Drug: JLP-1310
Group II
Experimental group
Description:
Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin
Treatment:
Drug: Metformin + Rosuvastatin
Drug: JLP-1310

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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