PHARMACOKINETICS AND PHARMACODYNAMICS.
The pharmacokinetics of dapoxetine hydrochloride have been evaluated in 3 main studies involving healthy male volunteers.
In the first study, a single oral dose of dapoxetine hydrochloride, 60 mg, was administered to 28 healthy male volunteers between the ages of 24 and 50 years (mean age, 37 years). The mean plasma half-life of dapoxetine was 1.53 hours (range, 1.11 to 2.07 hours). The mean apparent volume of distribution was 162 L (range, 141 to 183 L). The mean apparent total clearance of dapoxetine was 6.65 L/hour (range, 5.79 to 7.51 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 19.8 hours (range, 16.4 to 22.4 hours).
In the second study, a single oral dose of dapoxetine hydrochloride, 90 mg, was administered to 24 healthy male volunteers between the ages of 20 and 45 years (mean age, 33 years). The mean plasma half-life of dapoxetine was 1.40 hours (range, 1.13 to 1.67 hours). The mean apparent volume of distribution was 166 L (range, 147 to 186 L). The mean apparent total clearance of dapoxetine was 6.44 L/hour (range, 5.63 to 7.28 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 19.1 hours (ran
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In the third study, a single oral dose of dapoxetine hydrochloride, 120 mg, was administered to 21 healthy male volunteers between the ages of 18 and 45 years (mean age, 29 years). The mean plasma half-life of dapoxetine was 1.37 hours (range, 1.11 to 1.63 hours). The mean apparent volume of distribution was 171 L (range, 151 to 191 L). The mean apparent total clearance of dapoxetine was 6.31 L/hour (range, 5.48 to 7.15 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 18.9 hours (range, 16.3 to 21.6 hours).
In a fourth study, a single oral dose of dapoxetine hydrochloride, 60 mg, was administered to 18 healthy male volunteers between the ages of 21 and 40 years (mean age, 29 years). The mean plasma half-life of dapoxetine was 1.5 hours (range, 1.11 to 2.07 hours). The mean apparent volume of distribution was 162 L (range, 141 to 183 L). The mean apparent total clearance of dapoxetine was 6.65 L/hour (range, 5.79 to 7.51 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 19.8 hours (range, 16.4 to 22.4 hours).
In a fifth study, a single oral dose of dapoxetine hydrochloride, 90 mg, was administered to 16 healthy male volunteers between the ages of 21 and 40 years (mean age, 29 years). The mean plasma half-life of dapoxetine was 1.40 hours (range, 1.13 to 1.67 hours). The mean apparent volume of distribution was 166 L (range, 147 to 186 L). The mean apparent total clearance of dapoxetine was 6.44 L/hour (range, 5.63 to 7.28 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 19.1 hours (range, 16.4 to 21.8 hours).
In a sixth study, a single oral dose of dapoxetine hydrochloride, 120 mg, was administered to 12 healthy male volunteers between the ages of 21 and 40 years (mean age, 29 years). The mean plasma half-life of dapoxetine was 1.37 hours (range, 1.11 to 1.63 hours). The mean apparent volume of distribution was 171 L (range, 151 to 191 L). The mean apparent total clearance of dapoxetine was 6.31 L/hour (range, 5.48 to 7.15 L/hour). The mean apparent terminal plasma elimination half-life of dapoxetine was 18.9 hours (range, 16.3 to 21.6 hours).
In a seventh study, a single oral dose of dapoxetine hydrochloride, 60 mg, was administered to 21 healthy male volunteers between the ages of 18 and 45 years (mean age, 29 years). The mean plasma half-life of dap