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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01136551
• Collaborator: Hebrew University of Jerusalem (Other)
• Enrollment: 8
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Bioavailability	Drug: Huperzine A	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Sep 1, 2010
• Anticipated Primary Completion Date: Jan 1, 2011
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IR formulation Healthy volunteers will receive imediate release formulation of Huperzine A (0.4mg)	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.
Experimental: CR 1 CR formulation Healthy volunteers will receive controlled release formulation 1 of Huperzine A (0.4mg)	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.
Experimental: CR 2 CR formulation Same volunteers will receive controlled release formulation 2 of Huperzine A (0.4mg)	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.

Outcome Measures

Primary Outcome Measures

1. 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

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah University Hospital	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization
• Hebrew University of Jerusalem

Investigators

• Principal Investigator: Michael Friedman, Proffesor, Institute for Drug Research, Hebrew University of Jerusalem, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01136551
• Other Study ID Numbers: HUPA - CR- HMO-CTIL; HUPA-HU-1
• First Posted: Jun 3, 2010
• Last Update Posted: Jun 3, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Pharmacokinetic profile of controlled release formulation of Huperzine A; Bioequivalence of Huperzine A IR formulation and CR formulation
• Additional relevant MeSH terms: Huperzine A

Study Results

No Results Posted as of Jun 3, 2010