NCT03311022 is a Phase 1 clinical trial of Nefopam Hydrochloride 30mg Tablets in Healthy, sponsored by Galen Limited.

Who is sponsoring NCT03311022?

NCT03311022 is sponsored by Galen Limited.

What drugs are being tested in NCT03311022?

Interventions in NCT03311022: Nefopam Hydrochloride 30mg Tablets, Acupan® 30mg Tablets.

Is NCT03311022 still recruiting?

NCT03311022 is currently completed. Last updated 16 October 2017.

Last reviewed 2017-10-16 · How we verify

NCT03311022

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

Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy Subjects

Completed Phase 1 Last updated 16 October 2017

What this trial tests

Phase 1 trial testing Nefopam Hydrochloride 30mg Tablets in Healthy in 29 participants. Completed in 21 December 2015.

Timeline

6 November 2015

Primary endpoint
21 December 2015

21 December 2015

Quick facts

Lead sponsor	Galen Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	29
Start date	6 November 2015
Primary completion	21 December 2015
Estimated completion	21 December 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

Nefopam Hydrochloride 30mg Tablets — full drug profile →
Acupan® 30mg Tablets — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Galen Limited — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the bioavailability of Nefopam Hydrochloride 30mg Tablets (test product) and Acupan® 30mg Tablets (reference product).

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:

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Other Galen Limited trials

Trials by the same sponsor.

NCT06694662 — PKU EASY Microtabs Plus - Acceptability and Tolerance · NA · completed
NCT03280095 — Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects · Phase 1 · completed

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 NCT03311022 (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 Galen Limited
Last refreshed: 16 October 2017

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/NCT03311022.

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