NCT02941796

Brief Summary

To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

October 21, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

October 11, 2016

Last Update Submit

October 19, 2016

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (4)

  • 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)

  • Cmax of Rosuvastatin

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

  • AUCt of Rosuvastatin

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

Secondary Outcomes (10)

  • 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)

  • 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)

  • 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)

  • 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)

  • +5 more secondary outcomes

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: HCP1105Drug: HCP0918Drug: HCP0816

Sequence 2

EXPERIMENTAL

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

Drug: HCP1105Drug: HCP0918Drug: HCP0816

Interventions

HCP1105DRUG
Sequence 1Sequence 2
HCP0918DRUG
Sequence 1Sequence 2
HCP0816DRUG
Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 21, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-08

Locations

KR(1)