CompletedPhase 1ACTRN12615000304538

A Pharmacokinetic and Safety Study of the Chrono Nicotine Replacement Therapy System in male smokers.

A pharmacokinetic and safety study of the Chrono Nicotine Replacement Therapy System in male smokers.

Sponsor

Chrono Therapeutics Australia PTY LTD

Enrollment

12 participants

Start Date

Feb 16, 2015

Study Type

Interventional

Conditions

cigarette addiction

Summary

Phase 1 PK study with Descriptive statistics for Chrono Nicotine Replacement Therapy System (IDC-5) Including assessment of general safety

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

smokers
caucasians
male

Exclusion Criteria4

infections
opiate use
consume more than 2 alcoholic beverages a day
skin tattoos

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Interventions

Nicotine Replacement Therapy System 6 doses of 6% nicotine formulation over 24 hours. Doses delivered at T0, T1, T6, T7, T12, T13 transdermally administered using the Chrono IDC 5 device through a

Nicotine Replacement Therapy System 6 doses of 6% nicotine formulation over 24 hours. Doses delivered at T0, T1, T6, T7, T12, T13 transdermally administered using the Chrono IDC 5 device through a patch. Pharmacokinetic analysis and skin tolerability using a 7 point visual scale will be used.

Locations(1)

VIC, Australia

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ACTRN12615000304538