[Translation] A single-center, single-dose, randomized, open-label, two-sequence, two-period, two-crossover bioequivalence study of candecyrrhizic tablets in healthy subjects after fasting or after meals
主要目的:考察中国健康受试者在空腹/餐后条件下单次口服海南药谷云生物科技有限公司持有,江苏诚康药业有限公司生产的坎地氢噻片(规格:每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg)与CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片(商品名:Blopress®,规格:每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服坎地氢噻片受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of candesartan cilexetil tablets (specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) owned by Hainan Yaoguyun Biotechnology Co., Ltd. and produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. and candesartan cilexetil tablets (trade name: Blopress®, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) licensed by CHEPLAPHARM Arzneimittel GmbH in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test and reference preparations of candesartan cilexetil tablets taken orally at a single dose in healthy Chinese subjects.