Schall R, Müller F O, Duursema L, Groenewoud G, Hundt H K, Middle M V, Mogilnicka E M, Swart K J
Farmovs Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Bloemfontein, Republic of South Africa.
Arzneimittelforschung. 1995 Nov;45(11):1236-9.
Twenty male volunteers who were slow metabolisers of isoniazid, completed this single-blind, single-dose, randomised, cross-over study to compare the bioavailability of rifampicin (CAS 13292-46-1), isoniazid (CAS 54-85-3) and ethambutol (CAS 1070-11-7) from Myrin tablets (test preparation) with the bioavailability of these drugs from a combination of capsules containing rifampicin and tablets containing isoniazid and ethambutol (reference). There were 2 treatment periods and on clinic days volunteers were given either the reference (300 mig rifampicin plus 200 mg isoniazid and 600 mg ethambutol HCl), or the test preparation (300 mg rifampicin, 150 mg isoniazid and 600 mg ethambutol HCl). Serial blood samples were drawn from the volunteers and rifampicin, isoniazid and ethambutol assays were performed. The results of this study indicate that the test preparation is equivalent to the reference with respect to both the rate and the extent of absorption of rifampicin, isoniazid (after adjustment for the different doses of isoniazid and ethambutol).
20名异烟肼代谢缓慢的男性志愿者完成了这项单盲、单剂量、随机、交叉研究，以比较利福平（CAS 13292-46-1）、异烟肼（CAS 54-85-3）和乙胺丁醇（CAS 1070-11-7）的米利恩片（试验制剂）与含利福平胶囊和含异烟肼及乙胺丁醇片剂组合（参比制剂）的生物利用度。研究有2个治疗期，在门诊日，志愿者服用参比制剂（300mg利福平加200mg异烟肼和600mg盐酸乙胺丁醇）或试验制剂（300mg利福平、150mg异烟肼和600mg盐酸乙胺丁醇）。从志愿者采集系列血样并进行利福平、异烟肼和乙胺丁醇分析。本研究结果表明，就利福平、异烟肼（在调整异烟肼和乙胺丁醇不同剂量后）的吸收速率和程度而言，试验制剂与参比制剂等效。
