NCT01136551UnknownNot Applicable
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.
Hadassah Medical Organization1 site in 1 country8 target enrollmentStarted: September 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameters of Huperzine A different formulations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
IR formulation
Active Comparator
Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)
Intervention: Huperzine A (Drug)
CR 1
Experimental
CR formulation
Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg)
Intervention: Huperzine A (Drug)
CR 2
Experimental
CR formulation
Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg)
Intervention: Huperzine A (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (1)
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