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A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine

NCT03268343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-26

Study results available
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Summary

This will be an open-label, randomised, 2-period, single-dose crossover study to determine the comparative bioavailability of cytisine following single-dose administration in healthy male and female subjects under fed and fasted conditions.

The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.

Conditions

  • Smoking Cessation

Interventions

DRUG

Cytisine

Cytisine 1.5 mg Film-Coated Tablets

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, MD · Simbec Research Ltd (Simbec)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2017-08-26
Completion
2017-09-01
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03268343 on ClinicalTrials.gov