Status:
COMPLETED
A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-48 years
Phase:
PHASE1
Brief Summary
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet...
Detailed Description
This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet. All patien...
Eligibility Criteria
Inclusion
- All patients must meet the following criteria: body weight index is between 18-28 kg/m2
- Patients are deemed healthy based on physical examination, medical history, vital signs, electrocardiogram and results of clinical laboratory tests
- All patients must be able to read and understand the contents of informed consent that must be signed prior to any trial-specific procedures are done.
Exclusion
- Patients meeting one or more of the following criteria cannot be included in the study: the patient uses disallowed medicine, which is any prescribed medication within the last 2 weeks or OTC drugs within the last week prior to dosing (or at least 5 half lives for any drug ingested). Patients who have taken any non-prescribed systemic or topical medication may still be entered into the study, if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety
- The subject has history of alcohol or drug abuse
- Patient has been treated with an investigational drug within 30 days prior to screening
- Patient has a know hypersensitivity to galantamine or has a history of severe drug allergy or hypersensitivity
- Patient has any serious illness such as liver or renal insufficiency, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, metabolic and other chronic disturbance
- Patient has donated blood within 60 days prior to dosing
- Patient is a moderate or severe smoker who smokes more than 3 cigarettes, or ex-smokers who has ceased smoking for at least 3 months prior to dosing
- Patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00645554
End Date
September 1 2004
Last Update
May 19 2011
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