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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01136551
• Other study ID #: HUPA - CR- HMO-CTIL
• Secondary ID: HUPA-HU-1
• Status: Not yet recruiting
• Phase: N/A
• First received: June 2, 2010
• Last updated: June 2, 2010
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2010
• Source: Hadassah Medical Organization
• Contact: Gregory Burshtein, MA
• Phone: 97226758665/4
• Email: bursht[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability
• Healthy

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes