NCT02786043

PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses

An Open-label, Single Arm, Self-controlled Safety and Pharmacokinetics Study to Evaluate the Effect of Propionyl L-carnitine Hydrochloride on Healthy Chinese Subjects by Diet and Multiple-doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (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 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

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.

Conditions

• Peripheral Arterial Diseases

Interventions

Type	Name	Description
DRUG	Propionyl-L-Carnitine Hydrochloride	1g twice a day on first 4 days and 1g/ day on day 5 during Phase III

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