|Execution Standard:||USP42||Molecular Formula:||C21H23NO|
Oral Anabolic Steroid Mesterolone Sex Enhancement Powder CAS 119356-77-3
Melting point: 46-48°C(lit.)
Boiling point: 164°C
Flash Point: >230°F
Storage conditions: Keep in dark place, Inert atmosphere, Room temperature
Acidity coefficient (pKa): 9.59±0.10 (Predicted)
3,5-Dihydroxypentylbenzene is an important pharmaceutical intermediate, which was first obtained by degrading lichenic acid (also known as D-sunroic acid, pentyl icylic acid) extracted from lichen plants. 3,5-Dihydroxyalkylbenzene has a variety of biological activities, and has killing effect on fungi and bacteria of various pathogens. In recent years, it has been found that in the presence of copper chloride and oxygen, high concentrations of 3,5-dihydroxyalkylbenzene can fragment DNA. Therefore, it is used for inhibiting and treating human immunodeficiency, cancer and other malignant tumors caused by retrovirus, and the effect is remarkable.
The Phase II clinical trial was a multicenter, double-blind, randomized, controlled, and crosstalk study to evaluate the efficacy and safety of dapoxetine 60mg, 10omg, and placebo in the treatment of PE. 166 patients (age 18-65 years, IELT mean 1.olmin, single fixed heterosexual partner >; IELT was measured by the sexual partner using a stopwatch. The participants were divided into three groups and given dapoxetine 60,100 mg or placebo 1 to 3 hours before sexual activity. A total of 130 patients completed the trial, which showed a significant increase in IELT compared with placebo at all doses of dapoxetine (P&L; 0.0001). The mean pre-trial IELT was 1.0lmin, and the endpoints of the 100mg, 60mg and placebo groups were 3.20, 2.94 and 2.05min, respectively, and the first dose was effective. 0.00 1. The incidence of major adverse events, nausea, was 5.6%, 16.1%, and 0.7%, respectively. Of the 10 patients who withdrew from the trial due to adverse events, 9 were in the 100mg group, so the maximum dose of dapoxetine used in the phase 1 trial was 60mg.
The phase III clinical trial was designed to verify the efficacy and safety of dapoxetine for on-demand and on-time administration in patients with moderate to severe PE. In two 12-week multicentre, randomized, double-blind, controlled balance trials at 121 sites across the United States, 2614 patients received placebo (n=870), dapoxetine 30mg(n=874), and dapoxetine 60mg(n=870) one to three hours before sexual activity. The primary endpoint was measured by a stopwatch. The number of people who completed the trial was 627 in the placebo group, 676 in the 30mg group, and 610 in the 60mg group. The results showed that all doses of dapoxetine significantly prolonged IELT compared with placebo (P&L; 0001), and the first dose is effective. Pretrial placebo, 30mg and 60! IELT n9 groups respectively (0.90 + / - 0.47), (0.92-0.50) and (0.91 + 0.48) min, 12 weeks after the finish (1.75 + / - 2.21), respectively (" 8 + / - 3.48) and (3.32 + / - 3.68 min. Therefore, dapoxetine 30 and 60mg on time is effective and well tolerated in patients with moderate to severe PE. The major adverse reactions were nausea and headache.
The common adverse reactions of dapoxetine were nausea, diarrhea, dizziness and headache. In the phase 1 trial, nausea was highest at 20% in the 60mg group, with 10% of patients discontinued, dizziness was 6.2%, and diarrhea was 6.8%. The incidence of adverse reactions in single dose of 3OMG and 6OMG was 26.2% and 40.5%, respectively, and that in multiple doses was 45.2% and 40.5%, respectively. The occurrence of diarrhea, nausea and dizziness in DL was more common than that in DG. The incidence of adverse reactions in DS was similar to that in single dose, and most of them were mild to moderate. No serious adverse events, such as cardiovascular system, liver or blood system, were found.
There have been no reports of dapoxetine interacting with other drugs. In the pharmacokinetic studies of dapoxetine and phosphodiacetase inhibitors tetanafil and sildenafil, as well as ethanol, although sildenafil increased the AUC of dapoxetine by 2%, it had no clinical significance. There was no significant pharmacokinetic interaction between ethanol and dapoxetine.
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