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NCT03822546
A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
NA trial testing Conventional cigarette in Healthy Volunteers in 15 participants. Completed in 30 April 2018.
30 April 2018
Quick facts
| Lead sponsor | Fontem Ventures BV |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 1 April 2018 |
| Primary completion | 30 April 2018 |
| Estimated completion | 30 April 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Conventional cigarette
- myblu 25 mg freebase
- myblu 16 mg nicotine salt
- myblu 25 mg nicotine salt
- myblu 40 mg nicotine salt
- blu PRO 48 mg nicotine salt
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Fontem Ventures BV
Who can join
Adults 25 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers.
O'Connell G, Pritchard JD, Prue C, Thompson J, et al · · 2019 · cited 77× · PMID 30712148 · DOI 10.1007/s11739-019-02025-3
Verify or expand the search:
- PubMed search for NCT03822546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fontem Ventures BV trials
Trials by the same sponsor.
- NCT04019626 — A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03822546 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fontem Ventures BV
- Last refreshed: 30 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03822546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing