Abstract | BACKGROUND: METHODS/RESULTS: This single-dose, two-treatment, two-period, two-sequence, open-label, randomized crossover study was conducted on 32 healthy male volunteers. The average values for Cmax, Tmax, AUC0-t and AUC0-inf were 21.50 ng/ml, 3.85 h, 423.71 ng.h/ml and 489.26 ng.h/ml, for cyclizine 50 mg (test) versus 20.39 ng/ml, 4.34 h, 410.56 ng.h/ml and 473.86 ng.h/ml for Valoid 50 mg (reference). The 90% CI of the mean ratios of Cmax (geometric mean ratio: 101.81 ng/ml), and AUC0-t (101.81 ng.h/ml) were within the bioequivalence range of 80 to 125%. Both drugs were well tolerated. CONCLUSION:
Cyclizine 50 mg is bioequivalent to the reference.
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Authors | Dhiraj Abhyankar, Ashish Shedage, Milind Gole, Preeti Raut |
Journal | Therapeutic delivery
(Ther Deliv)
Vol. 7
Issue 8
Pg. 545-51
(08 2016)
ISSN: 2041-6008 [Electronic] England |
PMID | 27444494
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Adult
- Area Under Curve
- Biological Availability
- Cross-Over Studies
- Cyclizine
(administration & dosage, pharmacokinetics)
- Drug Compounding
- Healthy Volunteers
- Humans
- Male
- Middle Aged
- Tablets
- Therapeutic Equivalency
- Young Adult
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