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Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single‐Dose, 3‐Period Crossover Study
Author(s) -
Li Lei,
Zhang Xingfei,
Yang Guoping,
Huang Jie,
Yang Xiaoyan,
Ye Ling,
Guo Can,
Yang Shuang,
Wang Xiaomin
Publication year - 2021
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.890
Subject(s) - medicine , tolerability , pharmacokinetics , tazarotene , crossover study , pharmacology , clindamycin , dermatology , adverse effect , antibiotics , acne , alternative medicine , pathology , placebo , microbiology and biotechnology , biology
Abstract The current study compared the safety, tolerability, and pharmacokinetics of the new compound pharmaceutical preparation tazarotene clindamycin cream, and 2 single pharmaceutical preparations, tazarotene cream and clindamycin phosphate gel. Twelve healthy volunteers were enrolled in this single‐center, single‐blind, 3‐treatment, 3‐period crossover, single‐dose randomized study. An 800‐cm 2 area on volunteers’ backs was evenly smeared with 1.6 g of the test preparation to form a film. Blood samples were collected at predetermined time points for pharmacokinetic analysis. Safety and tolerability were assessed via skin reaction evaluation and clinical laboratory tests. The incidences of skin reactions were 18.2% for tazarotene clindamycin cream, 25.0% for tazarotene cream, and 18.2% for clindamycin phosphate gel. There were no significant differences in safety or tolerability among the 3 groups. Erythema, desquamation, and pruritus occurred in 7 volunteers, but no burning or tingling occurred. All adverse events were mild and resolved spontaneously, and there were no severe adverse events. The respective maximum plasma concentrations of tazarotenic acid after local administration of tazarotene clindamycin cream and tazarotene cream were 11 ± 5 pg/mL and 18 ± 12 pg/mL, and the areas under the curve within 72 hours were 444 ± 341 pg · h/mL and 692 ± 462 pg · h/mL.