PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses
NCT02786043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2016-05-30
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
Conditions
- Peripheral Arterial Diseases
Interventions
- DRUG
-
Propionyl-L-Carnitine Hydrochloride
1g twice a day on first 4 days and 1g/ day on day 5 during Phase III
Sponsors & Collaborators
-
Lee's Pharmaceutical Limited
lead INDUSTRY
Principal Investigators
-
Heng-yan Qu · National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2015-11-30
- Completion
- 2016-01-31
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