Bioavailability of Lipantil Capsule (Micronized) in Human Body
Huang Zhongyi
Abstract
Huang Zhongyi
Abstract
OBJECTIVE: To study bioequiavailability of two preparations of Lipantil capsule micronized in human body. METHODS: A total of 24 male healthy volunteers were assigned to receive lipantil capsules (test preparation) 160mg and common fenofibrate capsules (reference substance) 200mg in a randomized crossover way. Blood concentrations of the subjects were determined by HPLC and pharmacokinetic parameters and relative bioavailability were computed as well. RESULTS: The pharmacokinetic parameters of lipantil capsule vs. common fenofibrate capsule were as follows: tmax was (3.91±1.00) h vs. (3.74±0.86) h,Cmax was (10.33±3.26) μg/ml vs. (10.61±2.79) μg/ml, AUC0~72 was (173.54±56.04)(μg·h)/ml vs. (176.69±47.13) (μg·h)/ml,t1/2 was (22.25±3.78) h vs. (23.19±3.71) h. The relative bioavailability of lipantil capsule was (97.80±14.32) %. CONCLUSION: The two preparations nad the bio equiavailability.
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OBJECTIVE: To study bioequiavailability of two preparations of Lipantil capsule micronized in human body. METHODS: A total of 24 male healthy volunteers were assigned to receive lipantil capsules (test preparation) 160mg and common fenofibrate capsules (reference substance) 200mg in a randomized crossover way. Blood concentrations of the subjects were determined by HPLC and pharmacokinetic parameters and relative bioavailability were computed as well. RESULTS: The pharmacokinetic parameters of lipantil capsule vs. common fenofibrate capsule were as follows: tmax was (3.91±1.00) h vs. (3.74±0.86) h,Cmax was (10.33±3.26) μg/ml vs. (10.61±2.79) μg/ml, AUC0~72 was (173.54±56.04)(μg·h)/ml vs. (176.69±47.13) (μg·h)/ml,t1/2 was (22.25±3.78) h vs. (23.19±3.71) h. The relative bioavailability of lipantil capsule was (97.80±14.32) %. CONCLUSION: The two preparations nad the bio equiavailability.
Key concepts: Capsule, Bioavailability, Pharmacokinetics, Cmax, Fenofibrate, Bioequivalence, Chemistry, Crossover study