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A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects

NCT ID: NCT01497288

Last Updated: 2012-10-02

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Intranasal fentanyl spray Population PK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1 (A-B-C)

* A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1
* B: single dose of 400 μg INFS (100 μL), administered 4 hours after the first treatment
* C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 24 hours after the first treatment (Day 2)

Group Type EXPERIMENTAL

INFS (Intranasal Fentanyl Spray)

Intervention Type DRUG

Intranasal Fentanyl Spray

Sequence 2 (A-C-B)

* A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1
* C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 4 hours after the first treatment
* B: single dose of 400 μg INFS (100 μL), administered 24 hours after the first treatment (Day 2)

Group Type EXPERIMENTAL

INFS (Intranasal Fentanyl Spray)

Intervention Type DRUG

Intranasal Fentanyl Spray

Interventions

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INFS (Intranasal Fentanyl Spray)

Intranasal Fentanyl Spray

Intervention Type DRUG

Other Intervention Names

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(Instanyl®)

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria:

Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nycomed Investigational Site

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-002549-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-2623

Identifier Type: REGISTRY

Identifier Source: secondary_id

FT-1301-101-RD

Identifier Type: -

Identifier Source: org_study_id