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

NARecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 24, 2023

Primary Completion Date

December 14, 2023

Study Completion Date

March 31, 2024

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)."

Trial Locations (1)

SE-752 37

RECRUITING

Clinical Trial Consultants AB (CTC), Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amplicon AB

INDUSTRY