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LEO 80185ゲルの皮膚薬物動態試験

基本情報

NCT ID
NCT02605057
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
32
治験依頼者名
LEO Pharma

概要

Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.

対象疾患

Psoriasis Vulgaris

介入

LEO 80185 gel(DRUG)
Dovobet(r) Ointment(DRUG)

依頼者(Sponsor)

Leo(INDUSTRY)

実施施設 (1)

Shinanokai Shinanozaka Clinic

Tokyo, Japan