Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A
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| ClinicalTrials.gov Identifier: NCT01136551 |
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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
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Sponsor:
Hadassah Medical Organization
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
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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 |
|---|---|
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Active Comparator: IR formulation
Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)
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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. |
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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. |
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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 :
- 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 :
- 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 ]
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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:
- 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
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:
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Pharmacokinetic profile of controlled release formulation of Huperzine A Bioequivalence of Huperzine A IR formulation and CR formulation |
Additional relevant MeSH terms:
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Huperzine A Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents |
Neurotransmitter Agents Physiological Effects of Drugs Neuroprotective Agents Protective Agents |