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

Not Applicable

• Conditions: Healthy; Bioavailability
• Interventions: Drug: Huperzine A

• Registration Number: NCT01136551
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Posted: 2010-06-03
• Study Start: 2010-09
• Primary Completion: 2011-01
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IR formulation	Huperzine A	Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)
CR 2	Huperzine A	CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg)
CR 1	Huperzine A	CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Huperzine A different formulations	Blood samples will be taken for 36 hours after Huperzine A administration	Pharmacokinetic parameters: C max, T max, AUC, t1/2

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel