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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000304538

Enrollment

Registered

2015-04-01

Start date

2015-02-16

Completion date

2015-02-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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

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 patch. Pharmacokinetic analysis and skin tolerability using a 7 point visual scale will be used.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

smokers caucasians male

Exclusion criteria

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

Outcome results