Completed PHASE1 INTERVENTIONAL 2-arm NCT03432312

Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges

A Single-Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Two-Period Crossover Study to Determine the Bioequivalence of Two Nicotine Resinate Lozenge Formulations Containing Nicotine 4 mg in up to 42 Healthy Male and Female Smokers Under Fasting Conditions

Sponsor: Fertin Pharma A/S

Conditions Smoking Cessation

Interventions Nicotine lozenge

Updated 6 times since 2018 Last updated: Aug 8, 2018 Started: Jan 15, 2018 Primary completion: Feb 17, 2018 Completion: Feb 17, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Smoking Cessation and is currently completed. Fertin Pharma A/S leads this study, which shows 6 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Sep 2018 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Jun 2018 — Sep 2018 [monthly]

Recruiting PHASE1

▶ Show 1 earlier version

Mar 2018 — Jun 2018 [monthly]

Recruiting PHASE1

First recorded

Jan 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Fertin Pharma A/S

Data source: Fertin Pharma A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bloemfontein, South Africa