[Translation] An open-label, randomized, single-dose, two-formulation crossover bioequivalence study comparing a test formulation of cetirizine hydrochloride to Zyrtec® tablets under fasting and postprandial conditions
主要目的:
第 1 部分:
评价受试制剂盐酸西替利嗪片10 mg 与市售制剂盐酸西替利嗪片 10 mg(仙特明®盐酸西替利嗪片10 mg - UCB Farchim SA, Switzerland)在空腹条件下的生物等效性。
第 2 部分:
评价受试制剂盐酸西替利嗪片10 mg 与市售制剂盐酸西替利嗪片10 mg(仙特明®盐酸西替利嗪片10 mg - UCB Farchim SA, Switzerland)在餐后条件下的生物等效性。
次要目的:
评价盐酸西替利嗪的受试制剂和参比制剂在空腹(第 1 部分)和餐后(第 2 部分)条件下的安全性。
[Translation] main purpose:
part 1:
Evaluation of the biological effects of the test preparation Cetirizine Hydrochloride Tablets 10 mg and the commercial preparation Cetirizine Hydrochloride Tablets 10 mg (Zyrtec® Cetirizine Hydrochloride Tablets 10 mg - UCB Farchim SA, Switzerland) under fasting conditions Equivalence.
part 2:
Evaluation of the test preparation Cetirizine Hydrochloride Tablets 10 mg and the commercial preparation Cetirizine Hydrochloride Tablets 10 mg (Zyrtec® Cetirizine Hydrochloride Tablets 10 mg - UCB Farchim SA, Switzerland) under postprandial conditions Bioequivalence.
Secondary purpose:
To evaluate the safety of test and reference formulations of cetirizine hydrochloride under fasting (Part 1) and postprandial (Part 2) conditions.