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A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation

NCT03509948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-09-24

Study results available
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Summary

This will be an open-label, randomised, 2-treatment period, single-dose crossover study to determine the comparative bioavailability and renal elimination following single-dose administration of 3.0 mg cytisine in healthy smokers under fed and fasted conditions.

Conditions

  • Smoking Cessation

Interventions

DRUG

cytisine

cytisine 1.5 mg film-coated tablets

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Ezanul Abd Wahab, 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
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2018-06-10
Completion
2018-06-12
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 NCT03509948 on ClinicalTrials.gov