[Translation] Phase I clinical study on the safety and tolerability of eucalyptus, lemon and pinene soft capsules in healthy Chinese adult subjects and their pharmacokinetic characteristics compared with eucalyptus, lemon and pinene enteric-coated capsules
主要目的:评估桉柠蒎软胶囊单次给药在中国健康成年受试者中的安全性和耐受性。
次要目的:评估试验药物(改良制剂,桉柠蒎软胶囊)单次给药在中国健康成年受试者中的药代动力学(PK)特征;对比试验药物(改良制剂,桉柠蒎软胶囊)与对照药物(原制剂,桉柠蒎肠溶胶囊 切诺®)的药代动力学(PK)特征差异。
[Translation] Primary objective: To evaluate the safety and tolerability of a single dose of Eucalyptus, Lemon and Pinus Soft Capsules in healthy Chinese adult subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of the test drug (modified formulation, Eucalyptus, Lemon and Pinus Soft Capsules) in healthy Chinese adult subjects after a single dose; to compare the differences in pharmacokinetic (PK) characteristics between the test drug (modified formulation, Eucalyptus, Lemon and Pinus Soft Capsules) and the control drug (original formulation, Eucalyptus, Lemon and Pinus Enteric-coated Capsules Cherno®).