Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers

NCT02941848 | Completed Phase 1

• 1 other identifier: HM-ROZE-102
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults.

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

• AUClast of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• Cmax of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• AUClast of Free Ezetimibe

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• Cmax of Free Ezetimibe

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

Secondary Outcomes (12)

• AUCinf of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• tmax of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• t1/2 of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• CL/F of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

• Vd/F of Rosuvastatin

  Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

Study Arms (2)

Group1

EXPERIMENTAL

C → A + B A : HGP0816 B : HGP1404 C : HCP1306

Drug: HGP0816; Drug: HGP1404; Drug: HCP1306

Group2

EXPERIMENTAL

A + B → C A : HGP0816 B : HGP1404 C : HCP1306

Drug: HGP0816; Drug: HGP1404; Drug: HCP1306

Interventions

HGP0816 DRUG

Group1; Group2

HGP1404 DRUG

Group1; Group2

HCP1306 DRUG

Group1; Group2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult of 19 to 50 of age at screening.
• ≤ Body mass index (BMI) \< 25.
• ※ BMS (kg/m2)= body weight (kg)/\[height (m)2\]
• Body weight ≥ 55 kg for men and ≥ 50 kg for women.
• Individual considered by the responsible physician to be eligible as a subject based on the results of hematology test, blood chemistry test, immunoserology test, urinalysis, and electrocardiogram (ECG) as performed according to the characteristics of the drug (including those with not clinically significant (NCS) abnormalities).
• Women must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative pre-dose urine β-hCG test at a time point defined in the protocol and must be applicable to one of the followings.
• Postmenopausal (no spontaneous menstruation for at least 2 years)
• Surgical sterilization (sterilized by hysterectomy, bilateral ovariectomy or tubal ligation, or other methods)
• A male partner is sterilized prior to screening (documented azoospermia following vasectomy) and this man is the subject's only partner.
• The subject must agree to use adequate methods of contraception continuously and properly during the period of time from at least 14 days prior to the first dose to at least 28 days after the last dose of the investigational product.
• Adequate methods of contraception include abstinence and physical barrier methods (e.g., condom, diaphragm, or cervical cap) and contraceptive devices or pills containing hormones that may have drug-drug interactions with the investigational product are not to be used during the study period, in principle.
• Sexually active male subject with a female partner of childbearing potential must agree to avoid pregnancy (condom, etc.) during the study and to maintain adequate methods of contraception and not donate sperms during the study and for 28 days after the last dose of the investigational product (the methods of contraception are not necessary if the male subject or his female partner is sterile).
• After receiving and understanding sufficient explanations about the study, the individual must voluntarily decide to participate in the study and provide written informed consent to complying with study instructions.

You may not qualify if:

• Evidence or history of clinically significant diseases in the hepatobiliary system, kidney, nervous system, psychiatric system, respiratory system, endocrine system (thyroid dysfunction, etc.), hemato-oncology, cardiovascular system, immune system, or musculoskeletal system (myopathy, etc.).
• History of gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis) or surgery (except for simple typhlotomy or hernia repair) that may affect the absorption of the investigational product.
• Hypersensitivity reactions to any of the components of the investigational product or its excipients or drugs of the same class.
• Hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Vital signs measured in the sitting position after at least 5 minutes of rest as follows: systolic blood pressure (SBP) \> 150 mmHg or \< 90 mmHg or diastolic blood pressure (DBP) \> 100 mmHg or \< 50 mmHg.
• Screening clinical laboratory test results as follows:
• Blood total bilirubin level \> 1.5 x upper limit of normal (ULN)
• Blood aspartate aminotransferase (AST, also known as serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT, also known as serum glutamate pyruvate transaminase \[SGPT\]) \> 1.25 x ULN
• Blood urea nitrogen (BUN) \> 25.0 mg/dL or creatinine \> 1.4 mg/dL
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
• ※ eGFR (mL/min/1.73m2) = 175 x \[serum creatinine (mg/dL)\]-1.154 x \[age (years)\]-0.203 (X 0.742, if female)
• Blood Creatinine Phosphokinase (CK) \> 2 x ULN
• History of significant drug abuse within 1 year of screening or positive urine drug test results.
• Administration of drugs within 30 days of the investigational product administration that are expected to or may affect the metabolism of the investigational product.
• Administration of the following drugs within the relevant period, except for local agents without significant systemic absorption and hormonal contraceptives.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Related Publications (1)

• Min KL, Park MS, Jung J, Chang MJ, Kim CO. Comparison of Pharmacokinetics and Safety of a Fixed-dose Combination of Rosuvastatin and Ezetimibe Versus Separate Tablets in Healthy Subjects. Clin Ther. 2017 Sep;39(9):1799-1810. doi: 10.1016/j.clinthera.2017.07.038. Epub 2017 Aug 10.

  PMID: 28803122 DERIVED

Study Officials

• Choon Ok Kim, MD

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

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: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 21, 2016

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will not share