Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults

Hyundai Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BPDO-1603

Study type

Interventional

Funder types

Industry

Identifiers

NCT05804279

HT-007-05

Details and patient eligibility

About

Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study

Enrollment

24 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults aged 19 or older and 55 or less at the time of screening tests
Men weigh 55 kg or more and women weigh 50 kg or more
Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2

Exclusion criteria

Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history.
A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history
Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption