Oluka M O, Mitema E S, Kibwage I O, Kwasa T O, Kokwaro G O
Department of Pharmacology and Toxicology, University of Nairobi, Kenya.
East Afr Med J. 1996 May;73(5):323-6.
The relative bioavailabilities of three carbamazepine tablet formulations available in the Kenyan market (Temporal(R), Taver(R) and Carbamazepine Lincoln) compared with the innovator formulation (Tegretol(R)) were evaluated in seven healthy African volunteers (5 males, two females; aged 22-36 years), according to a randomised fourway crossover study design, following oral administration of single 200 mg doses with a three week washout period. In vitro dissolution profiles of the tablets were also evaluated. Relative bioavailabilities ((F)rel) of Temporal(R), Taver(R) and Carbamazepine Linocoln were 101.2%, 82.2% and 71.6% respectively, compared with Tegretol(R). Percent drug content dissolved in vitro after I hour were 91.3%, 75.9% and 39.3% for Temporal(R), Taver(R) and Carbamazepine Lincoln, respectively. It was concluded that Temporal(R) was bioequivalent to Tegretol(R) while Taver(R) and Carbamazepin Lincoln were bioinequivalent to Tegretol(R). Administration of Taver(R) or Carbamazepine Lincoln might lead to poor control of epileptic seizures.
根据随机四交叉研究设计，在7名健康的非洲志愿者（5名男性，2名女性；年龄22 - 36岁）中，对肯尼亚市场上三种卡马西平片剂制剂（Temporal(R)、Taver(R)和卡马西平林肯）与创新制剂（得理多(R)）的相对生物利用度进行了评估。这些志愿者口服单剂量200毫克药物，并有三周的洗脱期。还评估了片剂的体外溶出曲线。与得理多(R)相比，Temporal(R)、Taver(R)和卡马西平林肯的相对生物利用度（(F)rel）分别为101.2%、82.2%和71.6%。Temporal(R)、Taver(R)和卡马西平林肯在体外1小时后溶解的药物含量百分比分别为91.3%、75.9%和39.3%。得出的结论是，Temporal(R)与得理多(R)生物等效，而Taver(R)和卡马西平林肯与得理多(R)生物不等效。服用Taver(R)或卡马西平林肯可能导致癫痫发作控制不佳。
