CompletedPhase 1ACTRN12615000098538

Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal Healthy Volunteers

A single site, open label study to evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy adult volunteers.

Sponsor

Zenith Technology Corp Ltd

Enrollment

10 participants

Start Date

Jan 16, 2015

Study Type

Interventional

Conditions

Pharmacodynamic effects study conducted in healthy volunteers with no health condition or problem studied. This study is being conducted in healthy volunteers who are not being treated for the conditions that anatabine citrate are indicated for. Anatabine citrate is a naturally occurring alkaloid found in the Solanaceae plant family. It is also the ingredient of a number of dietary supplements.

Summary

To evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy volunteers.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria6

Males or females
In good general health
Aged between 18-65 years of age inclusive
Weighing between 45 and 100 kg
Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator
Normal ECG

Exclusion Criteria5

Current users of tobacco (cigarettes or smokeless)
Current user of anatabine citrate dietary supplements
Allergy to any of the product ingredients
Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
Participation in any drug or medical device study within 30 days of entering this study

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Interventions

Single dose study where each participant receives one dose of anatabine citrate on one occasion. The dosage will be either 3 or 4 mg oral tablet based on body weight taken with 240 ml water. If the

Single dose study where each participant receives one dose of anatabine citrate on one occasion. The dosage will be either 3 or 4 mg oral tablet based on body weight taken with 240 ml water. If the subject weighs less than or equal to 81.4 kg the dose given will be 3 mg. If the subject weighs 81.5 kg or above they will receive 4 mg. The intervention for this trial is the test formulation of anatabine citrate. All subjects will receive their dosage and blood samples will be collected immediately prior to dosing and then one hour after dosing via venipuncture. Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety.

Locations(1)

Otago, New Zealand

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ACTRN12615000098538