NCT02786069

A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Propionyl L-carnitine Hydrochloride	500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2016-05-30
• Last updated: 2016-05-30