Pharmacokinetics of single and multiple escalating doses of dapoxetine in healthy volunteers
Abstract
Objective To characterize the pharmacokinetics and safety of single and multiple doses of dapoxetine, a novel agent under development for the treatment of premature ejaculation, a urogenital disorder. Methods: This was a randomized, double-blind, placebo-controlled, single and multiple dose study in 77 healthy male volunteers. Dapoxetine was administered orally as a single dose of 60, 100, 140, or 160 mg or once-daily for 6 days at 80, 100, or 120 mg. Pharmacokinetic parameters were determined by non-compartmental methods. Safety was evaluated by physical exam; laboratory, vital signs and ECG measurements; and monitoring of adverse events. Results: Dapoxetine was quickly absorbed with peak plasma concentrations occurring at ~1.5 h after dosing followed by a rapid decline in plasma concentrations. Cmax and AUC increased proportionally up to 100 mg. Dapoxetine had a terminal half-life of ~18 h. Single- and multiple-dose pharmacokinetics were comparable. No serious adverse events were reported, and there were no clinically relevant changes in any clinical laboratory tests, vital signs, or ECG. Nausea, the most common adverse event, was mild or moderate. Conclusions: Following oral administration, dapoxetine was rapidly absorbed; a fast decline in plasma concentrations followed. Dapoxetine was well tolerated following single and multiple doses to healthy volunteers. Clinical Pharmacology & Therapeutics (2004) 75, P32–P32; doi: 10.1016/j.clpt.2003.11.123
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 77 participants or records.
Read the paper
Related studies
- Improving the translation of search strategies using the Polyglot Search Translator: a randomized controlled trial
- Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial
- Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study
- A randomized, controlled trial of oral propranolol in infantile hemangioma
- Clinical phenotypes of delirium during critical illness and severity of subsequent long-term cognitive impairment: a prospective cohort study
- Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.