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

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ClinicalTrials.gov Identifier: NCT01136551
Recruitment Status : Unknown
Verified May 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2010
Last Update Posted : June 3, 2010
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization

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 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

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.




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136551


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

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    Key Record Dates
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