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Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

NCT02974361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-03

No results posted yet for this study

Summary

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.

This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.

A total of 30 subjects will take part in the study; 10 per study part.

The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Ibuprofen

DRUG

Ibuprofen Lysine

DRUG

Ibuprofen-LDH

Sponsors & Collaborators

  • Oxford Pharmascience Ltd

    lead INDUSTRY

Principal Investigators

  • Annelize Koch · Simbec Orion Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-04-28
Completion
2017-05-03

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02974361 on ClinicalTrials.gov