Trials / Completed
CompletedNCT03509948
A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cytisine | cytisine 1.5 mg film-coated tablets |
Timeline
- Start date
- 2018-04-27
- Primary completion
- 2018-06-10
- Completion
- 2018-06-12
- First posted
- 2018-04-27
- Last updated
- 2019-09-24
- Results posted
- 2019-09-12
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03509948. Inclusion in this directory is not an endorsement.