Diclofenac SR fast or fed state study design [Design Issues]

posted by xtianbadillo – Mexico, 2018-03-09 19:31 (1324 d 07:42 ago) – Posting: # 18518
Views: 5,025

» Hello, I need your advice please for diclofenac SR 75 mg:
» should study be conducted in fasting or fed state?

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm188529.pdf

Active ingredient: Diclofenac Sodium
Form/Route: Extended Release Tablets/Oral
Recommended studies: 2 studies

1. Type of study: Fasting
Design: Single-dose, two-way, crossover in-vivo
Strength: 100 mg
Subjects: Healthy males and nonpregnant females, general population.
Additional Comments:
______________________________________________________________________________
2. Type of study: Fed
Design: Single-dose, two-way, crossover in-vivo
Strength: 100 mg
Subjects: Healthy males and nonpregnant females, general population.
Additional comments:
_______________________________

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