SUNCETIN
CEFUROXIME
SUNCETIN TAB
500 mg Film-Coated Tablet
Antibacterial
DAY TO DAY PROTECTION AGAINST INFECTION
CEFUROXIME SODIUM
SUNCETIN IV
750 mg Powder for injection (I.M./I.V)
Antibacterial
CEFUROXIME
SUNCETIN TAB
500 mg Film-Coated Tablet
750 mg Powder for Injection (I.M./I.V.)
ANTIBACTERIAL
WINS THE BATTLE OF DAY-TODAY INFECTIONS!
STUDY DESIGN
A randomized, single dose, two treatment, two period, two sequence, open label, cross-over study with a wash out period of 5 days.
OBJECTIVES
To compare the comparative bioequivalence of Cefurixime Axelfil 500 mg Tablet Test Productd: SUNCETIN
(Cefuroxime Acetil) Tablet containing Cefuro Axetil 500 mg. of Glaxo SmithKline Ltd.
SAFETY RESULTS:
Twenty Four (24) non smoking, healthy male subjects were enrolled and completed the study with an group ranging from 19-40 years old.
SAFETY CONCLUSIONS:
There was no adverse event reported in the study.
STATISTICAL RESULTS:
The percentage ratios of least square means of SUNCETIN vs Reference Product were found to be com[arable for C(101.11%). AUC (102.98%) & AUC ( 102.92%)
The 90% CI of Log transformed date comparing test for C WAS 98.64 – 103.67% for AUC It was 95.14 – 108.80% and for AUC it was 95.16 – 108.69%. All values are between the acceptance criteria of 80%-125%
Based on the above data SUNCETIN meets the Bioequivalence criteria, when compared with reference product.
Formulation
SUNCETIN TAB
Each film-coated tablet contains:
| Cefurox Axetil USP eq. to Cefuroxime |
|---|
| 500 mg |
SUNCETIN IV
Each vial contains:
| Cefuroxime(as Sodium) |
|---|
| 750 mg |
View Complete Product Information
SUNCETIN TAB
500 mg Film-Coated Tablet Antibacterial DAY TO DAY PROTECTION AGAINST INFECTION CEFUROXIME SODIUMSUNCETIN IV
750 mg Powder for injection (I.M./I.V) Antibacterial CEFUROXIME SUNCETIN TAB 500 mg Film-Coated Tablet 750 mg Powder for Injection (I.M./I.V.) ANTIBACTERIAL WINS THE BATTLE OF DAY-TODAY INFECTIONS! STUDY DESIGNA randomized, single dose, two treatment, two period, two sequence, open label, cross-over study with a wash out period of 5 days.
OBJECTIVES To compare the comparative bioequivalence of Cefurixime Axelfil 500 mg Tablet Test Productd: SUNCETIN (Cefuroxime Acetil) Tablet containing Cefuro Axetil 500 mg. of Glaxo SmithKline Ltd.
SAFETY RESULTS: Twenty Four (24) non smoking, healthy male subjects were enrolled and completed the study with an group ranging from 19-40 years old. SAFETY CONCLUSIONS: There was no adverse event reported in the study. STATISTICAL RESULTS: The percentage ratios of least square means of SUNCETIN vs Reference Product were found to be com[arable for C(101.11%). AUC (102.98%) & AUC ( 102.92%) The 90% CI of Log transformed date comparing test for C WAS 98.64 - 103.67% for AUC It was 95.14 - 108.80% and for AUC it was 95.16 - 108.69%. All values are between the acceptance criteria of 80%-125% Based on the above data SUNCETIN meets the Bioequivalence criteria, when compared with reference product.
