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Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

NCT ID: NCT02974361

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-05-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A Ibuprofen control

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Part A Ibuprofen-LDH

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part A Ibuprofen-LDH Excipient Combo 1

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part A Ibuprofen-LDH Excipient Combo 2

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part A Ibuprofen-LDH Excipient Combo 3

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part A Ibuprofen-LDH Excipient Combo 4

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part A Ibuprofen Lysine

Group Type ACTIVE_COMPARATOR

Ibuprofen Lysine

Intervention Type DRUG

Part B Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Part B Ibuprofen LDH Excipient Combo 1

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part B Ibuprofen LDH Excipient Combo 2

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part B Ibuprofen LDH Excipient Combo 3

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part B Ibuprofen LDH Excipient Combo 4

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part C Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Part C Ibuprofen LDH Excipient Combo 1

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part C Ibuprofen LDH Excipient Combo 2

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part C Ibuprofen LDH Excipient Combo 3

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Part B Ibuprofen LDH Excipient Combo 5

Group Type EXPERIMENTAL

Ibuprofen-LDH

Intervention Type DRUG

Interventions

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Ibuprofen

Intervention Type DRUG

Ibuprofen Lysine

Intervention Type DRUG

Ibuprofen-LDH

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects
* BMI 18 - 30 kg/m2
* Willing and able to provide written informed consent

Exclusion Criteria

* Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
* Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
* Allergy or sensitivity to NSAIDs
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oxford Pharmascience Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annelize Koch

Role: PRINCIPAL_INVESTIGATOR

Simbec Orion Ltd

Locations

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Simbec Orion Ltd

Merthyr Tydfil, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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OAT-01

Identifier Type: -

Identifier Source: org_study_id

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