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

NCT01136551 | Unknown DMC

• 2 other identifiers: HUPA - CR- HMO-CTILHUPA-HU-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Bioavailability

Keywords

Pharmacokinetic profile of controlled release formulation of Huperzine A; Bioequivalence of Huperzine A IR formulation and CR formulation

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of Huperzine A different formulations

  Pharmacokinetic parameters: C max, T max, AUC, t1/2

  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.

  36 hours

Study Arms (3)

IR formulation

ACTIVE COMPARATOR

Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)

Drug: Huperzine A

CR 1

EXPERIMENTAL

CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg)

Drug: Huperzine A

CR 2

EXPERIMENTAL

CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg)

Drug: Huperzine A

Interventions

Huperzine A DRUG

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.

CR 1; CR 2; IR formulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Hadassah University Hospital

Jerusalem, Israel

Location

MeSH Terms

Interventions

huperzine A

Study Officials

• Michael Friedman, Proffesor

  Institute for Drug Research, Hebrew University of Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Burshtein, MA

CONTACT

97226758665/4; bursht@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 3, 2010

Record last verified: 2010-05

Locations

IL (1)