Clinical trial NCT01136551: Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A
Official title: An Open-label, Three-period, Crossover Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Different Release Rate Controlled Release Formulations of Huperzine A (0.4mg)Compared to the Equivalent Dose of an Immediate Release Formulation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Bioavailability
Keywords: Pharmacokinetic profile of controlled release formulation of Huperzine A
Bioequivalence of Huperzine A IR formulation and CR formulation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2010-06-03
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 cure to neurodegenerative disorders.


Eligibility criteria: Inclusion Criteria:

1. Healthy males between the age of 18 and 35, inclusive (ASA = 1)
2. Body weight \> 50 kg
3. Subject has a BMI less than 27 and more than 20
4. Participants should be able to ingest oral medication
5. The ability to understand and sign a written informed consent form, prior to participation and the willingness to comply with all study requirements

Exclusion Criteria:

1. History of drug sensitivity or drug allergy
2. History of sensitivity to eggs
3. Subject has a BMI less than 20 and more than 27
4. Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the current study
5. History of alcoholism or drug addiction
6. 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
7. 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)
8. Inability to relate to and/or cooperate with the investigators
9. Blood loss or donation greater than 200ml in the 3 months prior to the trial
10. Exhausting physical exercise during the previous 48 hours to drug administration
11. Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry

Primary outcomes:
measure: Pharmacokinetic parameters of Huperzine A different formulations
timeFrame: Blood samples will be taken for 36 hours after Huperzine A administration
Secondary outcomes:
measure: Laboratory testing of peripheral AchE inhibition by Huperzine A. Evaluation of adverse events. Laboratory testing of peripheral AchE inhibition by Huperzine A. Evaluation of adverse events.
timeFrame: 36 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Institute for Drug Research, Hebrew University of Jerusalem, Israel
name: Michael Friedman, Proffesor
role: PRINCIPAL_INVESTIGATOR
References: