HealthyNCT01136551
Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A
A study testing Huperzine A in people with Healthy and Bioavailability, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Bioavailability
- What is being tested?
- Huperzine A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Hospital
Jerusalem
Eliad Davidson, MD, 97226776911, edavidson@hadassah.org.il
About this study
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.
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.
- Conditions
- Healthy, Bioavailability
- Being tested
- Huperzine A
- Keywords
- Pharmacokinetic profile of controlled release formulation of Huperzine A, Bioequivalence of Huperzine A IR formulation and CR formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine ADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IR formulation | Active comparator | Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg) Receives: Drug: Huperzine A |
| CR 1 | Experimental | CR formulation
Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg) Receives: Drug: Huperzine A |
| CR 2 | Experimental | CR formulation
Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg) Receives: Drug: Huperzine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of Huperzine A different formulations
Pharmacokinetic parameters: C max, T max, AUC, t1/2
Measured: Blood samples will be taken for 36 hours after Huperzine A administration
Secondary outcomes (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.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Michael Friedman, Proffesor, Principal investigator, Institute for Drug Research, Hebrew University of Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136551
- Sponsor's protocol ID
- HUPA - CR- HMO-CTIL
- Other IDs
- HUPA-HU-1
- Status last verified
- May 2010
- First submitted
- 2 Jun 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01136551
- Acronym / sponsor ID
- HUPA - CR- HMO-CTIL
- Conditions
- Healthy, Bioavailability
- Keywords
- Pharmacokinetic profile of controlled release formulation of Huperzine A, Bioequivalence of Huperzine A IR formulation and CR formulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IR formulation | Active comparator | Drug: Huperzine AHealthy volunteers will receive imediate release formulation of Huperzine A (0.4mg) |
| CR 1 | Experimental | Drug: Huperzine ACR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg) |
| CR 2 | Experimental | Drug: Huperzine ACR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huperzine AEach 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. | Drug | CR 1, CR 2, IR formulation |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Friedman, Proffesor principal investigator
Institute for Drug Research, Hebrew University of Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huperzine A in people with Healthy and Bioavailability, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory Burshtein, MA (97226758665/4, bursht@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters of Huperzine A different formulations (time frame: Blood samples will be taken for 36 hours after Huperzine A administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010; AzTrials last refreshed its copy on 29 Oct 2026.