Status:
UNKNOWN
Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Hebrew University of Jerusalem
Conditions:
Healthy
Bioavailability
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to develop oral controlled release formulation of Huperzine A that will provide optimal pharmacokinetic profile of the drug enhancing safety and compliance, as possible cu...
Eligibility Criteria
Inclusion
- Healthy males between the age of 18 and 35, inclusive (ASA = 1)
- Body weight \> 50 kg
- Subject has a BMI less than 27 and more than 20
- Participants should be able to ingest oral medication
- The ability to understand and sign a written informed consent form, prior to participation and the willingness to comply with all study requirements
Exclusion
- History of drug sensitivity or drug allergy
- History of sensitivity to eggs
- Subject has a BMI less than 20 and more than 27
- Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the current study
- History of alcoholism or drug addiction
- Any medication taken including over-the-counter medications and herbal products within 14 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the investigator and if not contraindicated, may be continued at the same dose and frequency during the study period
- History of clinically important illness (ASA\>1); Disorders or conditions that could affect the absorption, distribution, metabolism and/or excretion of drugs (e.g. malabsorption, edema, renal or hepatic insufficiency)
- Inability to relate to and/or cooperate with the investigators
- Blood loss or donation greater than 200ml in the 3 months prior to the trial
- Exhausting physical exercise during the previous 48 hours to drug administration
- Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01136551
Start Date
September 1 2010
End Date
April 1 2011
Last Update
June 3 2010
Active Locations (1)
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1
Hadassah University Hospital
Jerusalem, Israel