Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Healthy; Bioavailability	Drug: Huperzine A	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	8 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	September 2010
Estimated Primary Completion Date :	January 2011
Estimated Study Completion Date :	April 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: IR formulation; Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)	Drug: Huperzine A; Each volunteer will receive single dose of three different formulations of Huperzine A. One immediate release formulation of 0.4mg and two different controlled release formulations at same dose. Between the study phases will be a washout period of at least 21 days.
Experimental: CR 1; CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg)	Drug: Huperzine A; Each volunteer will receive single dose of three different formulations of Huperzine A. One immediate release formulation of 0.4mg and two different controlled release formulations at same dose. Between the study phases will be a washout period of at least 21 days.
Experimental: CR 2; CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg)	Drug: Huperzine A; Each volunteer will receive single dose of three different formulations of Huperzine A. One immediate release formulation of 0.4mg and two different controlled release formulations at same dose. Between the study phases will be a washout period of at least 21 days.

Outcome Measures

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Primary Outcome Measures :

1. Pharmacokinetic parameters of Huperzine A different formulations [ Time Frame: Blood samples will be taken for 36 hours after Huperzine A administration ]
   Pharmacokinetic parameters: C max, T max, AUC, t1/2

Secondary Outcome Measures :

1. 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. [ Time Frame: 36 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Gregory Burshtein, MA	97226758665/4	bursht@gmail.com

Locations

Israel
Hadassah University Hospital	Not yet recruiting
Jerusalem, Israel
Contact: Eliad Davidson, MD 97226776911 edavidson@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Hebrew University of Jerusalem

Investigators

Principal Investigator:	Michael Friedman, Proffesor	Institute for Drug Research, Hebrew University of Jerusalem, Israel

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eliad Davidson, MD, School of pharmacy, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier:	NCT01136551 History of Changes
Other Study ID Numbers:	HUPA - CR- HMO-CTIL; HUPA-HU-1 ( Registry Identifier: Haddasah University Hospital )
First Posted:	June 3, 2010
Last Update Posted:	June 3, 2010
Last Verified:	May 2010

Keywords provided by Hadassah Medical Organization:

Pharmacokinetic profile of controlled release formulation of Huperzine A; Bioequivalence of Huperzine A IR formulation and CR formulation

Additional relevant MeSH terms:

Huperzine A; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents	Neurotransmitter Agents; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents