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

Hadassah Medical Center

Status: Unknown

Conditions: Healthy; Bioavailability

Treatments: Drug: Huperzine A

Study type: Interventional

Funder types: Other

Identifiers

NCT01136551

HUPA-HU-1 (Registry Identifier)

HUPA - CR- HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

IR formulation

Active Comparator group

Description:

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

Treatment:

Drug: Huperzine A

CR 1

Experimental group

Description:

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

Treatment:

Drug: Huperzine A

CR 2

Experimental group

Description:

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

Treatment:

Drug: Huperzine A