Ogunbona F A, Adedoyin P A, Olaniyi A A
Afr J Med Med Sci. 1985 Mar-Jun;14(1-2):21-5.
The chemical and biological equivalence of two brands of diazepam tablets marketed in Nigeria were compared to that of Valium (Roche) tablets. The tablets used were Relanium (Polfa) and Tropium (Biode). Bioequivalence studies of the brands were carried out on nine healthy volunteers by monitoring the cumulative diazepam excreted as oxazepam (both free and conjugated) in urine over 48 h. The bioequivalence of Relanium was found not to be significantly different from that of Valium while that of Tropium was significantly different from that of Valium (P less than 0.05). The results of the investigation showed that the drug products were all chemical equivalents but not biological equivalents.
对在尼日利亚销售的两个品牌的地西泮片剂与安定（罗氏）片剂的化学和生物等效性进行了比较。所使用的片剂为Relanium（Polfa公司）和Tropium（Biode公司）。通过监测9名健康志愿者在48小时内尿液中以奥沙西泮（游离和结合形式）排出的地西泮累积量，对这些品牌进行了生物等效性研究。发现Relanium与安定的生物等效性无显著差异，而Tropium与安定的生物等效性有显著差异（P小于0.05）。调查结果表明，这些药品都是化学等效物，但不是生物等效物。
