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

NCT03311022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-10-16

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Nefopam Hydrochloride 30mg Tablets

DRUG

Acupan® 30mg Tablets

Sponsors & Collaborators

  • Galen Limited

    lead INDUSTRY

Principal Investigators

  • Neil Fawkes, MBChB · BioKinetic Europe Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2015-12-21
Completion
2015-12-21

Countries

  • United Kingdom

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 NCT03311022 on ClinicalTrials.gov