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

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: INFS (Intranasal Fentanyl Spray) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Takeda

Summary

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.

Clinical Details

Official title: An Open Label, Randomised, Single-centre, Two Sequence, Cross-over 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 Using a Population PK Approach

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Nycomed Investigational Site, Mannheim 68157, Germany
Additional Information

Starting date: November 2011
Last updated: September 28, 2012

Page last updated: August 23, 2015

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