vitamin-D-resistant; rickets (manifestation)

Main research purpose: This study uses the calcitriol soft capsules (specification: 0.25μg) certified by Zhuhai Jianfu Pharmaceutical Co., Ltd. as the test preparation and the calcitriol capsules (trade name: Luogaiquan®, specification: 0.25μg) certified by Atnahs Pharma UK Limited as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

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, Dalian Meichuang 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 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.