Ismail Al-Shathar, A., Hasson Aziz, S., Awad Al-Shammary, A. (2017). A randomized, single dose, two treatment, two period, crossover bioequivalence study of cefixime (as trihydrate) suspension in healthy participants comparing Acacime® suspension produced by ACAI / Iraq to Suprax® suspension produced by Hikma / Jordan. , 17(1), 163-169.
Ahmad Ismail Al-Shathar; Samir Hasson Aziz; Adil Awad Al-Shammary. "A randomized, single dose, two treatment, two period, crossover bioequivalence study of cefixime (as trihydrate) suspension in healthy participants comparing Acacime® suspension produced by ACAI / Iraq to Suprax® suspension produced by Hikma / Jordan". , 17, 1, 2017, 163-169.
Ismail Al-Shathar, A., Hasson Aziz, S., Awad Al-Shammary, A. (2017). 'A randomized, single dose, two treatment, two period, crossover bioequivalence study of cefixime (as trihydrate) suspension in healthy participants comparing Acacime® suspension produced by ACAI / Iraq to Suprax® suspension produced by Hikma / Jordan', , 17(1), pp. 163-169.
Ismail Al-Shathar, A., Hasson Aziz, S., Awad Al-Shammary, A. A randomized, single dose, two treatment, two period, crossover bioequivalence study of cefixime (as trihydrate) suspension in healthy participants comparing Acacime® suspension produced by ACAI / Iraq to Suprax® suspension produced by Hikma / Jordan. , 2017; 17(1): 163-169.

A randomized, single dose, two treatment, two period, crossover bioequivalence study of cefixime (as trihydrate) suspension in healthy participants comparing Acacime® suspension produced by ACAI / Iraq to Suprax® suspension produced by Hikma / Jordan

Al-Mustansiriyah Journal for Pharmaceutical Sciences
Article 1, Volume 17, Issue 1, 2017, Pages 163-169
Authors
Ahmad Ismail Al-Shathar; Samir Hasson Aziz; Adil Awad Al-Shammary
Abstract
Formulation of drugs affects their access into human body, thus bioequivalence studies are conducted to assess therapeutic equivalence between medicines which are produced by dif-ferent manufacturers. In this study, bioequivalence of two cefixime formulations as powder for suspension, Acacime® manufactured by Arab Co. for Antibiotics Industries (ACAI) / Iraq, and Suprax®, manufactured by the Jordanian Co., Hikma, is tested. Twenty-four sub-jects had participated in the study which was designed as, a randomized, single dose, two pe-riod, crossover study. Cefixime concentrations in plasma were measured by validated bioana-lytical method, using high-performance liquid chromatography with UV detection. The de-termined pharmacokinetics parameters were Cmax, AUC0–t and AUC0–∞ for cefixime. The mean results obtained for Acacime® and Suprax® were, for C max: 2.736 and 2.395 µg/ml, for AUC0–t: 16.787 and 16.579 µg/ml*h and, for AUC0–∞: 21.011 and 21.685 µg/ml*h, re-spectively. The 90% confidence intervals for AUC0-t, AUC0-∞ and Cmax were 92.3 – 110.8%, 84.8 – 102.7% and 96.3 – 117.9% respectively. This study revealed that both prod-ucts were comparable in efficacy and safety, so they are considered as bioequivalent products and can be used interchangeably.
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