Pharmacokinetics of Anatabine Clinical Trial
Official title:
3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK
Parts 1 and 2:
Subjects take 1 dose of various formulations of the study product, and provide samples for
pharmacokinetic (PK) analysis after each, with at least 7 days between doses.
Part 3:
Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and
provides samples for PK analysis.
Parts 1 and 2:
Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will
fast overnight and receive the study product in the morning of Day 1 in a non-randomized
manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical
unit at 36 and 48 h post-dose to provide a sample for PK analysis.
There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days
after the final dose to ensure his/her ongoing well-being.
Part 3:
Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will
fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once,
twice, or three times a day regimen in a randomized, double-blind manner. Subjects will
remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of
Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis.
Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing
well-being.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science