A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of HDDO-1756 or Loose Combination of HDDO-17561/HDDO-17562 in Healthy Adult Volunteers

Hyundai Pharmaceutical Co., LTD.1 site in 1 country56 target enrollmentJune 12, 2020

ConditionsHyperlipidemias

InterventionsHDDO-1756 HDDO-17561/HDDO-17562

DrugsHDDO-1756 HDDO-17561/HDDO-17562

Overview

Phase: Phase 1
Intervention: HDDO-1756
Conditions: Hyperlipidemias
Sponsor: Hyundai Pharmaceutical Co., LTD.
Enrollment: 56
Locations: 1
Primary Endpoint: pharmacokinetic evaluation variables
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.

Registry

clinicaltrials.gov

Start Date

June 12, 2020

End Date

July 27, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Hyundai Pharmaceutical Co., LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult volunteers aged 19 or older during screening
•A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less.
•☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2
•A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
•A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests.

Exclusion Criteria

•Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history:
•Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
•Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;