Pharmacokinetics and Safety of Dapoxetine Hydrochloride in Healthy Chinese Men : Impact of Dose and High‐Fat Meal
Abstract Dapoxetine is the first oral medication specifically developed for the on‐demand treatment of premature ejaculation. The pharmacokinetics and safety of 30 mg (n = 40) and 60 mg (n = 38) dapoxetine in healthy Chinese under fasted and fed states were assessed in 2 studies. Both studies are random, single‐center, 2‐period, open‐label, 2‐way crossover designs. Plasma concentration of dapoxetine was determined by high‐performance liquid chromatography–tandem mass spectrometry, and the pharmacokinetic parameters were calculated using noncompartmental analysis. Dapoxetine was quickly absorbed and reached maximum concentration 1 to 3 hours after oral administration. Elimination was biphasic, and the plasma concentration decreased to 3% to 7% of maximum concentration by 24 hours while half‐life was 15 to 18 hours. Meantime, high‐fat meals slightly increased its exposure. Both doses of dapoxetine were well tolerated. The adverse events in the high‐dose group under fasted and fed states were 37.9% and 19.0%, respectively..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Clinical Pharmacology in Drug Development - 10(2021), 10, Seite 1216-1224 |
| Beteiligte Personen: |
Liu, Jingyan [VerfasserIn] |
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| BKL: |
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| Anmerkungen: |
© American College of Clinical Pharmacology |
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| Umfang: |
9 |
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| doi: |
10.1002/cpdd.919 |
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| funding: |
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| 520 | |a Abstract Dapoxetine is the first oral medication specifically developed for the on‐demand treatment of premature ejaculation. The pharmacokinetics and safety of 30 mg (n = 40) and 60 mg (n = 38) dapoxetine in healthy Chinese under fasted and fed states were assessed in 2 studies. Both studies are random, single‐center, 2‐period, open‐label, 2‐way crossover designs. Plasma concentration of dapoxetine was determined by high‐performance liquid chromatography–tandem mass spectrometry, and the pharmacokinetic parameters were calculated using noncompartmental analysis. Dapoxetine was quickly absorbed and reached maximum concentration 1 to 3 hours after oral administration. Elimination was biphasic, and the plasma concentration decreased to 3% to 7% of maximum concentration by 24 hours while half‐life was 15 to 18 hours. Meantime, high‐fat meals slightly increased its exposure. Both doses of dapoxetine were well tolerated. The adverse events in the high‐dose group under fasted and fed states were 37.9% and 19.0%, respectively. | ||
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