A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Galantamine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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