Seoul National University Hospital Clinical Trials Center
Seoul, 110-744, South Korea
NCT Number: NCT02309008
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.
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Notify Me19 year–65 year
Male
Interventional
Phase 1
Seoul, 110-744, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive PAC-14028 cream applied topically once a day for 9 days
Other names: PAC-14028 cream 0.1%, PAC-14028 cream 0.3%, PAC-14028 cream 1.0%
Participants will receive vehicle cream applied topically once a day for 9 days
Other names: Vehicle cream
Time frame: 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
Time frame: Day 1: 0 ~ 16h ; Day 2~8: 0h ; Day 9: 0 ~ 96h
Concentration of PAC-14028 in Blood; Cmax, AUC
Amorepacific Corporation
Industry
A Randomized, Double-blind, Placebo-controlled Multiple Dosing Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream After Transdermal Administration in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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