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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01136551
First received: June 2, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention
Healthy
Bioavailability
Drug: Huperzine A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Pharmacokinetic parameters of Huperzine A different formulations [ Time Frame: Blood samples will be taken for 36 hours after Huperzine A administration ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters: C max, T max, AUC, t1/2


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: September 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 2, 2010
Last Updated: June 2, 2010
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

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
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014