This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
* Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours * Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours
Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water
Inha University Hospital
Incheon, South Korea
Pharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
Time frame: 0~240 hours after medication
Pharmacokinetic variables - maximum observed plasma concentration(Cmax) of BR4002 and BR4002-1
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
Time frame: 0~240 hours after medication
Pharmacokinetic variables - Area Under the concentration-time Curve from time 0 to infinite after single dosing(AUCinf) of BR4002 and BR4002-1
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
Time frame: 0~240 hours after medication
Pharmacokinetic variables - Time of occurrence of Cmax(Tmax) of BR4002 and BR4002-1
PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.
Time frame: 0~240 hours after medication
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