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

NCT02786043 Phase 1 COMPLETED

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

Details

Lead sponsor	Lee's Pharmaceutical Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2015-06
Completion	2016-01

Conditions

• Peripheral Arterial Diseases

Interventions

• Propionyl-L-Carnitine Hydrochloride

Primary outcomes

• Area Under Curve (AUC) — Day 3 and 4, 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after drug administration on day 5
  To observe area under curve characteristics of Propionyl-L-Carnitine in single or multiple dose groups