Phase I Clinical Study of Dexamethasone Cipecilate (NS-126C), a Steroid Nasal Spray, in Single- and Repeated-dose Administration
| Autor: | Minoru Okuda |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Drug
medicine.diagnostic_test business.industry media_common.quotation_subject medicine.medical_treatment Metabolite Physical examination Urine chemistry.chemical_compound medicine.anatomical_structure Otorhinolaryngology Nasal spray chemistry Pharmacokinetics Throat Anesthesia medicine Adverse effect business media_common |
| Zdroj: | Practica Oto-Rhino-Laryngologica. 103:85-98 |
| ISSN: | 1884-4545 0032-6313 |
| DOI: | 10.5631/jibirin.103.85 |
| Popis: | Dexamethasone cipecilate (NS-126C), a new steroid nasal spray in powder form, is effective in once-a-day administration. We conducted a placebo-controlled, double-blind phase I clinical study in single administration at 50 μg, 100 μg, 200 μg, or 400 μg and repeated administration at 200 μg or 400 mg once a day for 14 days in healthy adults to determine NS-126C safety and pharmacokinetics. An analysis of subjective symptoms, objective findings, anterior rhinoscopy, laboratory tests, adrenal function tests, physical examination, throat or nasal fungal tests, and nasal ciliary function tests showed only 1 adverse event for which a causal relationship to the study drug could not be ruled out, i.e. 1 case of mild throat discomfort in 1 subject given the drug at 100 μg in the single-dose study. No adverse effect on adrenal function was observed. In pharmacokinetic examination, plasma levels of the unchanged drug and its principal metabolite, DX-17-CPC, and the level of unchanged drug in urine were less than the quantitation limit of |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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