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

NCT00645554 | Completed Phase 1

• 1 other identifier: CR002848
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacokinetics

Keywords

Galantamine oral solution; Galantamine tablet; Bioequivalence

Outcome Measures

Primary Outcomes (1)

• It is estimated that the plasma maximal concentration of galantamine (Cmax=31.53mg×L-1) after single oral administration can be reached in Chinese young volunteers at the peak time of 1.66 hours. The half life is 7.06 hours.

Secondary Outcomes (1)

• The relative bioavialibility of galantamine oral solution (4mg) indicated by AUC0-t and AUC0-inf are 105.6%±18.5% and 106.2%±19.5% respectively.

Interventions

Galantamine oral solution DRUG

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Related Links

• A bioequivalent study of galantamine oral solution comparing with galantamine tablet in healthy Chinese male subjects

MeSH Terms

Interventions

Galantamine

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xian-Janssen Pharmaceutical Ltd. Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Completion: September 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-03