PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses

2016-05-31 15:08:22 | BioPortfolio


The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration


This is a single group subject, open-label, self-controlled, 3 periods, multi-doses administration trial. 12 Healthy Chinese volunteers satisfying inclusion criteria were enrolled with equal number of male and female. Each subject goes through a 7-day Run-in period to eliminate the remaining L-carnitine like substance in the food to ensure the baseline level of endougenous L-Carnitien is stable;In period III, during the first 4 days,all healthy subjects take oral Propionyl-L-Carnitine 1g twice daily; on day 5, all healthy subjects take oral Propionyl-L-Carnitine 1g during fasting.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Peripheral Arterial Diseases


Propionyl-L-Carnitine Hydrochloride




Lee's Pharmaceutical Limited

Results (where available)

View Results


Published on BioPortfolio: 2016-05-31T15:08:22-0400

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