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

posted by xtianbadillo – Mexico, 2018-03-09 20:31 (1846 d 12:08 ago) – Posting: # 18518
Views: 5,367

❝ 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:
_______________________________

Complete thread:

UA Flag
Activity
 Admin contact
22,557 posts in 4,724 threads, 1,608 registered users;
9 visitors (0 registered, 9 guests [including 3 identified bots]).
Forum time: 09:39 CEST (Europe/Vienna)

A scientist’s aim in a discussion with his colleagues
is not to persuade, but to clarify.    Leo Szilard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5