The main objective is to evaluate the effect of single dose 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.
Before the official start of the study, to determine the appropriate dosing interval and a preliminary assessment of drug safety, first carried out the pre-trial, 4 subjects with different gender in half, after 7 days of run-in period, collect baseline background sampling point at day 4, no medication but water intake. At day 8 fasting oral propionyl L-carnitine hydrochloride tablets 0.5g, according to pre-designed schedule for blood samples, urine samples and clinical indicators, provide a reference for official trial. Official trial is a single, open label, self-controlled, three-period, dose escalation, period fasting single oral administration trial. 12 chinese healthy adult subject met the inclusion criteria 12 people, each gender in half. Each subject first pass 7 days of run-in period, to eliminate the residual substances in food L-carnitine, stable baseline level of endogenous L-carnitine class substance within the subject; at day 4 was baseline sampling point, tno medication but water intake; at day 8 (1st period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 1g; at day 12 (2nd period of day 1) fasting oral hydrochloride propionyl L-carnitine tablets 2g; the first 16 days (3rd period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 4g.Throughout the trial period, control the subjects' diet, eating only allowed as far as possible food without substance L-carnitine class and drink boiled water,diet at sampling day 4, 8, 12, 16 need to be fixed consistently. Every 4 days of dosing interval washout period. Subject need to follow blood, urine collection and diet control as required by protocol before the day of run-in period. During the trial should avoid vigorous exercise, meanwhile to avoid long-time bedding.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.
Area Under Curve (AUC)
To observe area under curve characteristics of propionyl L-carnitine hydrochloride in single dose oral 1, 2, 4g
Time frame: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration
cumulative excretion percentage
To estimate cumulative excretion percentage from the urine drug concentration in single dose oral 1, 2, 4g propionyl L-carnitine hydrochloride tablets
Time frame: after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection
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