Status:
COMPLETED
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
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 subjec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01497288
Start Date
November 1 2011
End Date
December 1 2011
Last Update
October 2 2012
Active Locations (1)
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1
Nycomed Investigational Site
Mannheim, Germany, 68157