A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

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Detailed Description

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This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.

Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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12 hourly capsule fasted

4 mg 12 hourly capsule - strong pain killer fasted

Group Type ACTIVE_COMPARATOR

4 mg 12 hourly capsule - strong pain killer fed

Intervention Type DRUG

12 hourly capsule fed

4 mg 12 hourly capsule - strong pain killer fed

Group Type ACTIVE_COMPARATOR

4 mg 12 hourly capsule - strong pain killer fasted

Intervention Type DRUG

12 hourly capsule with antagonist fasted

4 mg 12 hourly capsule strong painkiller with antagonist fasted

Group Type EXPERIMENTAL

4 mg 12 hourly capsule strong painkiller with antagonist fed

Intervention Type DRUG

12 hourly capsule with antagonist fed

4 mg 12 hourly capsule strong painkiller with antagonist fed

Group Type EXPERIMENTAL

12 hourly capsule strong painkiller with antagonist fasted)

Intervention Type DRUG

Interventions

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4 mg 12 hourly capsule - strong pain killer fasted

Intervention Type DRUG

4 mg 12 hourly capsule - strong pain killer fed

Intervention Type DRUG

12 hourly capsule strong painkiller with antagonist fasted)

Intervention Type DRUG

4 mg 12 hourly capsule strong painkiller with antagonist fed

Intervention Type DRUG

Other Intervention Names

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MR2XXX MR2XXX MR2XXX MR2XXX

Eligibility Criteria

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Inclusion Criteria

Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes