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
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