Healthy
Conditions
Keywords
Pharmacokinetics
Brief summary
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.
Interventions
DRUGPAC-14028
Participants will receive PAC-14028 cream applied topically once a day for 9 days
OTHERVehicle
Participants will receive vehicle cream applied topically once a day for 9 days
Sponsors
Seoul National University Hospital
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men aged 19 to 65 years at the time of screening 2. Whose weight is 50 kg or more, but less than 90 kg, and whose body mass index (BMI) is 18.0 kg/m\^2 or more but less than 27 kg/m\^2 * BMI (kg/m\^2) = weight(kg) /{height(m)}\^2 3. Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption 4. Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception
Exclusion criteria
1. Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system,skin, psychical disorders or blood tumor 2. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc) 3. Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins within 1 week before the study drug initiation (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/Tolerability (adverse events, abnormal vital signs, ECG test, clinical lab tests, Numerical pain recording scale) | Day 1~9, at specified time for each tests | AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests, Numerical pain recording scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (Concentration of PAC-14028 in Blood; Cmax, AUC) | Day 1: 0 ~ 16h ; Day 2~8: 0h ; Day 9: 0 ~ 96h | Concentration of PAC-14028 in Blood; Cmax, AUC |
Countries
South Korea
Outcome results
None listed