Shandong Jiandao Pharmaceutical Co., Ltd.

Main study objectives To study the pharmacokinetic (PK) characteristics of calcitriol in healthy Chinese subjects after a single oral administration of calcitriol capsules (specification: 0.25μg, Shandong Jiandao Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25μg, Rogaquan®; licensee: Roche Pharma (Schweiz) AG) in fasting and fed states, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives To evaluate the safety of the test preparation calcitriol capsules and reference preparation calcitriol capsules in healthy Chinese subjects after a single oral administration in fasting and fed states.

main purpose: Study the single oral administration of the test preparation idecalcitol soft capsule (specification: 0.75 μg, provided by Shandong Jiandao Pharmaceutical Co., Ltd.) and the reference preparation idecalcitol soft capsule (Edirol®; specifications) in fasting and postprandial states. : 0.75μg; license holder: Chugai Co., Ltd.), by comparing the pharmacokinetic parameters of the test preparation and the reference preparation in vivo absorption and metabolism of healthy subjects under fasting and postprandial conditions, the human biological effects of the two preparations were evaluated. Equivalence. Secondary purpose: To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation idecalcitol soft capsules and the reference preparation idecalcitol soft capsules in fasting and postprandial states.