Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

H. Lundbeck A/S12 enrolled

Overview

The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

RasagilineDRUG

1 mg/day, tablets for 7 days, orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The subject is a Chinese man or woman * The subject is, in the opinion of the investigator, generally healthy * If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit Exclusion Criteria: * The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and exclusion criteria may apply.

Locations (1)

CN001

Beijing, China

Outcomes

Primary Outcomes

Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)

Time frame: 7 days

PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)

Time frame: 7 days

Secondary Outcomes

Number of patients with adverse events as a measure of safety and tolerability

Time frame: 7 days

Data from ClinicalTrials.gov

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