Who is sponsoring NCT01887847?

NCT01887847 is sponsored by Pharmaceutical Productions Inc..

What drugs are being tested in NCT01887847?

Interventions in NCT01887847: Nicotine (Pharmaceutical Productions Inc.), Nicotine (Pharmaceutical Productions Inc.).

What condition does NCT01887847 study?

NCT01887847 studies Nicotine Pharmacokinetic Study.

Is NCT01887847 still recruiting?

NCT01887847 is currently completed. Last updated 28 March 2016.

Last reviewed 2016-03-28 · How we verify

NCT01887847

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, 2 Way Crossover, Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablets ( Pharmaceutical Productions Inc.) Versus COMMIT Smoking Lozenge ( GLAXOSMITHKLINE) in Healthy Smoking Volunteers

Completed Phase 1 Last updated 28 March 2016

What this trial tests

Phase 1 trial testing Nicotine (Pharmaceutical Productions Inc.) in Nicotine Pharmacokinetic Study in 6 participants. Completed in 1 August 2014.

Timeline

1 June 2013

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Pharmaceutical Productions Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 June 2013
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	1 location across United States

Drugs / interventions tested

Nicotine (Pharmaceutical Productions Inc.) — full drug profile →
Nicotine (Pharmaceutical Productions Inc.) — full drug profile →

Conditions studied

Nicotine Pharmacokinetic Study — all drugs for Nicotine Pharmacokinetic Study →

Sponsor

Pharmaceutical Productions Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Nicotine Pharmacokinetic Study. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The primary outcome measure is to substantiate that the pharmacokinetics of this novel nicotine replacement therapy (NRT) resembles that of smoking a cigarette, wherein the average Tmax is about 15 minutes or less. ►
Time frame: Serial blood samples will be obtained at the following times after the administration of the nicotine dosage forms: 0, 4, 8, 10, 12, 16, 30, 45, 60, 90, 120, and 180 minutes.

Sponsor's own description

The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

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:

Other recruiting trials for Nicotine Pharmacokinetic Study

Currently open trials in the same condition.

NCT07128329 — Acute Effects of Oral Nicotine Pouches · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01887847 (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 Pharmaceutical Productions Inc.
Last refreshed: 28 March 2016

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/NCT01887847.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing