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

NCT ID: NCT01136551

Last Updated: 2010-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IR formulation

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

Group Type: ACTIVE_COMPARATOR

Huperzine A

Intervention Type: 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 formulation

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

Group Type: EXPERIMENTAL

Huperzine A

Intervention Type: 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 2

CR formulation

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

Group Type: EXPERIMENTAL

Huperzine A

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

School of pharmacy, Hebrew University of Jerusalem

Principal Investigators

Michael Friedman, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Institute for Drug Research, Hebrew University of Jerusalem, Israel

Locations

Hadassah University Hospital

Jerusalem, , Israel

Countries

Israel

Central Contacts

Gregory Burshtein, MA

Role: CONTACT

bursht@gmail.com

97226758665/4

Facility Contacts

Eliad Davidson, MD

Role: primary

edavidson@hadassah.org.il

97226776911

Other Identifiers

HUPA-HU-1

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUPA - CR- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id