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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy, Bioavailability

Intervention / Treatment
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* Drug: Huperzine A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IR formulation<br>Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg) | Drug: Huperzine A<br>* 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.<br>|
| Experimental: CR 1<br>CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg) | Drug: Huperzine A<br>* 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.<br>|
| Experimental: CR 2<br>CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg) | Drug: Huperzine A<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of Huperzine A different formulations | Pharmacokinetic parameters: C max, T max, AUC, t1/2 | Blood samples will be taken for 36 hours after Huperzine A administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic profile of controlled release formulation of Huperzine A, Bioequivalence of Huperzine A IR formulation and CR formulation