Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects
Lead Sponsor:
Amorepacific Corporation
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Healthy
Eligibility:
MALE
19-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy men aged 19 to 65 years at the time of screening
- 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
- Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption
- 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
- 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
- Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
- 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/exclusion criteria is satisfied.)
- Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
- Who has smoked within 3 months before study drug administration (Smoker who has stopped smoking for more than 3 months before study drug administration is eligible to participate)
- Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- Who consistently consumes alcohol
- Who has participated in other clinical study within 8 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
- Who has had bleeding or blood collection and donation over 400 mL within 8 weeks before study drug administration
- Who donated whole blood within 2 months before study drug administration, who donated via plasmapheresis/plateletpheresis within 1 month before study drug administration, or who received a blood transfusion within 1 month before study drug administration
- Whose vital sign measured at sitting position after resting at least 3 minutes is as following
- Low blood pressure (Systolic pressure: less than 90 mmHg, Diastolic pressure: less than 60 mmHg)
- High blood pressure (Systolic pressure: higher than 150 mmHg, Diastolic pressure: higher than 100 mmHg)
- Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02309008
Start Date
November 1 2014
Last Update
April 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital Clinical Trials Center
Seoul, South Korea, 110-744