A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese
|ClinicalTrials.gov Identifier: NCT02786069|
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : May 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: Propionyl L-carnitine Hydrochloride||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Self-controlled, Three-period Dynamics Single-dose Escalation Safety and Pharmacokinetics Study for Propionyl L-carnitine Hydrochloride Tablets of Healthy Subjects in China|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||January 2016|
|Experimental: Single arm||
Drug: Propionyl L-carnitine Hydrochloride
500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.
- Area Under Curve (AUC) [ Time Frame: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration ]To observe area under curve characteristics of propionyl L-carnitine hydrochloride in single dose oral 1, 2, 4g
- cumulative excretion percentage [ Time Frame: after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection ]To estimate cumulative excretion percentage from the urine drug concentration in single dose oral 1, 2, 4g propionyl L-carnitine hydrochloride tablets
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786069
|Principal Investigator:||Heng-yan Qu||National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences|