The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- DiabetesHyperlipidemia
- Interventions
- Registration Number
- NCT02982798
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- 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
- Detailed Description
A randomized, open-label, single dose, crossover clinical trial
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group I Metformin + Rosuvastatin Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310 Group II JLP-1310 Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin Group II Metformin + Rosuvastatin Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin Group I JLP-1310 Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310
- Primary Outcome Measures
Name Time Method AUClast of Metformin and rosuvastatin 48 hours Cmax of Metformin and rosuvastatin 48 hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the pharmacokinetic interactions between JLP-1310, metformin SR, and rosuvastatin in healthy male volunteers?
How does JLP-1310 compare to standard-of-care drugs for diabetes and hyperlipidemia in terms of efficacy and safety profiles?
What biomarkers are associated with the combined effects of metformin and rosuvastatin in managing metabolic syndrome and cardiovascular risk?
What adverse events are reported in phase 1 trials involving JLP-1310 and its combination with other antidiabetic or lipid-lowering agents?
How do the molecular mechanisms of JLP-1310 complement or contrast with those of metformin and rosuvastatin in treating diabetes and hyperlipidemia?
Trial Locations
- Locations (1)
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Inha University Hospital🇰🇷Incheon, Korea, Republic of