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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propionyl L-carnitine Hydrochloride | Drug | 500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | To observe area under curve characteristics of propionyl L-carnitine hydrochloride in single dose oral 1, 2, 4g | 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection |
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Inclusion Criteria:
Exclusion Criteria:
Subjects having one or more cannot be selected for the trial:
Laboratory parameters:
Medication history:
Disease history and surgical history:
Lifestyle:
Others:
Female subjects in addition to the above criteria, fulfilling any one of the following criteria must be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Heng-yan Qu | National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |