Status and phase
Conditions
Treatments
About
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
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Laboratory investigations:
Drug history:
Past medical history and surgical history:
Lifestyle:
Others:
For female subjects, any following criteria met, apart from criteria above, should also be excluded:
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal