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Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers

Primary Purpose

Hyperlipidemias

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HCP1105

HCP0918

HCP0816

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Inje University Busan Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab

R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab

Outcomes

Primary Outcome Measures

baseline-corrected Cmax of DHA total lipid & EPA total lipid

baseline-corrected AUCt of DHA total lipid & EPA total lipid

Cmax of Rosuvastatin

AUCt of Rosuvastatin

Secondary Outcome Measures

Cmax of DHA total lipid & EPA total lipid

AUCt of DHA total lipid & EPA total lipid

Tmax of DHA total lipid & EPA total lipid

t1/2β of DHA total lipid & EPA total lipid

baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid

AUC∞ of Rosuvastatin

Tmax of Rosuvastatin

t1/2β of Rosuvastatin

CL/F of Rosuvastatin

Vdz/F of Rosuvastatin

Full Information

NCT ID

NCT02941796

First Posted

October 11, 2016

Last Updated

October 19, 2016

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT02941796

Brief Title

Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers

Official Title

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics and Safety After Administration of HCP1105 Alone and Co-administration of HGP0918 and HGP0816 in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab

Intervention Type

Drug

Intervention Name(s)

HCP1105

Intervention Type

Drug

Intervention Name(s)

HCP0918

Intervention Type

Drug

Intervention Name(s)

HCP0816

Primary Outcome Measure Information:

Title

baseline-corrected Cmax of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

baseline-corrected AUCt of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

Cmax of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Title

AUCt of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Secondary Outcome Measure Information:

Title

Cmax of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

AUCt of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

Tmax of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

t1/2β of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid

Time Frame

-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

Title

AUC∞ of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Title

Tmax of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Title

t1/2β of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Title

CL/F of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Title

Vdz/F of Rosuvastatin

Time Frame

0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Inje University Busan Paik Hospital

City

Busan

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers

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