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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemias

Treatments: Drug: HCP1105; Drug: HCP0816; Drug: HCP0918

Study type: Interventional

Funder types: Industry

Identifiers

NCT02941796

HM-ROMA-106

Details and patient eligibility

About

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

Full 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

Enrollment: 68 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: HCP1105

Drug: HCP0816

Drug: HCP0918

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: HCP1105

Drug: HCP0816

Drug: HCP0918