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Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users

NCT06170138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-12-14

No results posted yet for this study

Summary

This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users.

Conditions

  • Nicotine Use Disorder

Interventions

OTHER

Test product 1 - Test product 2 - Comparator product

Each subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order. Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4).

Sponsors & Collaborators

  • Amplicon AB

    lead INDUSTRY

Principal Investigators

  • Erik Rein-Hedin, MD · Clinical Trial Consultants AB (CTC)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2023-12-14
Completion
2024-03-31

Countries

  • Sweden

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 NCT06170138 on ClinicalTrials.gov