Publication: Plasma concentration-time profile of a single dose of enteric-coated omeprazole in male and female healthy volunteers
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Date
2000-01-01
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Abstract
O b je c tiv e : T h e b io a vaila b ility of a single dose
(20 m g) o f tw o e n te ric -c o a te d o m e p ra z o le
fo rm u la tio n s, m arketed in T urkey, given 10-15
m in b e fo re b reakfast, w as studied in 12 healthy
vo lu n te e rs (6 m ales and 6 fem ales) in a d o u b le
blind, cro s s o v e r design.
M e th o d s : B lood sam ples w ere collected prior to
and at 10 tim e points w ithin 12 hrs. after dosing.
P la s m a o m e p ra z o le c o n c e n tra tio n s w e re
m easured by H P LC te ch n iq u e in our laboratory.
R e s u lts a n d C o n c lu s io n s : T he tw o products
w ere found to be b io e q u iva le n t in term s of extent
of a b s o rp tio n (th e a re a u n d e r the p la s m a
c o n c e n tra tio n -tim e cu rve s). M u ltip e a k p la sm a
co n ce n tra tio n pro file s w e re seen in m ost of the
su b je cts w ith both products. T im e to the e a rlie r
peaks w as 1-2 hrs. and those peaks w ere low er
in a m p litu d e th a n th e p e a ks re a ch e d
a p p ro x im a te ly 4 .5 hrs. a fte r the a p p lica tio n .
In te re stin g ly, the m u ltip e a k profile w as m ore
fre q u e n t and the e a rlie r peaks w ere sig nificantly
higher in fe m a le su b je cts than in m ales. The
reason fo r th is g e n d e r d iffe re n ce in m ultipeak
p la s m a c o n c e n tra tio n - tim e p ro file of oral
o m e p ra zo le needs fu rth e r investigation.
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Keywords
Tıp, Sağlık Bilimleri, Temel Tıp Bilimleri, Medicine, Health Sciences, Fundamental Medical Sciences, Klinik Tıp (MED), Klinik Tıp, TIP, GENEL & DAHİLİ, Clinical Medicine (MED), CLINICAL MEDICINE, MEDICINE, GENERAL & INTERNAL, Genel Tıp, General Medicine, Bioavailability, Coated capsules, Enteric, Gender difference, Omeprazole, Omeprazole, Bioavailability, Enteric, coated capsules, Gender difference
Citation
Iskender E., ASLAN N., GÖREN M. Z., Tellioglu T., Akin S., Erin N., GÜLHAN R., ONAT F., Berkman K., Oktay S., "Plasma concentration-time profile of a single dose of enteric-coated omeprazole in male and female healthy volunteers", Marmara Medical Journal, cilt.13, sa.3, ss.127-130, 2000