Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers
- Registration Number
- NCT02941796
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
- Detailed Description
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
- Healthy male volunteers, aged 19 to 55 years.
- The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
- Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 HCP0816 T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab Sequence 1 HCP1105 T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab Sequence 1 HCP0918 T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab Sequence 2 HCP1105 R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab Sequence 2 HCP0918 R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab Sequence 2 HCP0816 R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
- Primary Outcome Measures
Name Time Method Cmax of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) baseline-corrected Cmax of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) baseline-corrected AUCt of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) AUCt of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
- Secondary Outcome Measures
Name Time Method Tmax of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) AUCt of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) Tmax of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) CL/F of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) Vdz/F of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) Cmax of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) t1/2β of DHA total lipid & EPA total lipid -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) t1/2β of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) AUC∞ of Rosuvastatin 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Trial Locations
- Locations (1)
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of