Study identifier:D1120C00024
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Phase I, open-label, randomized, 2-way crossover study to assess relative bioavailability of single oral dose of naproxen as PN400 compared to naproxen as Naprosyn E under fasting and fed conditions in healthy volunteers
Healthy
Phase 1
Yes
PN400, Naproxen
All
48
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body’s uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.
Location
Location
Uppsala, Sweden
Location
Lulea, Sweden
Arms | Assigned Interventions |
---|---|
Experimental: 1 PN400 | Drug: PN400 oral tablet Other Name: VIMOVO™ |
Active Comparator: 2 Naprosyn E | Drug: Naproxen oral tablet Other Name: Naprosyn E |
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