HDDO-1756 Bio Equivalence Study

Hyundai Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Hyperlipidemias

Treatments

Drug: HDDO-17561/HDDO-17562

Drug: HDDO-1756

Study type

Interventional

Funder types

Industry

Identifiers

NCT04755894

HT-013-01

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

Male

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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;