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NCT04755348
A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
NA trial testing Product A in Tobacco Use in 36 participants. Completed in 25 March 2021.
20 March 2021
Quick facts
| Lead sponsor | British American Tobacco (Investments) Limited |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 18 February 2021 |
| Primary completion | 20 March 2021 |
| Estimated completion | 25 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Tobacco Use — all drugs for Tobacco Use →
- Tobacco Smoking — all drugs for Tobacco Smoking →
- Cigarette Smoking — all drugs for Cigarette Smoking →
Sponsor
British American Tobacco (Investments) Limited
Who can join
Adults 21 to 60, any sex, with Tobacco Use or Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04755348
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Product A
Trials testing the same drug.
- NCT07323563 — A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems · NA · not yet recruiting
- NCT07323511 — Abuse Liability for Eight Electronic Nicotine Products · NA · not yet recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT06777784 — Modern Nicotine Oral Product Abuse Liability · NA · completed
- NCT06356610 — Pharmacokinetic and Subjective Effects of Heated Tobacco Products · NA · completed
Other recruiting trials for Tobacco Use
Currently open trials in the same condition.
- NCT07162935 — Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY) · NA · recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness · Phase 4 · recruiting
- NCT06983678 — Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chron · NA · recruiting
- NCT06922617 — STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking · NA · recruiting
Other British American Tobacco (Investments) Limited trials
Trials by the same sponsor.
- NCT05142436 — BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heate · NA · completed
- NCT04846088 — A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers · NA · completed
- NCT03272295 — A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients · NA · completed
- NCT03178981 — E-cigarette Nicotine Pharmacokinetic Study · 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 NCT04755348 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by British American Tobacco (Investments) Limited
- Last refreshed: 30 March 2021
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/NCT04755348.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing