Relative bioavailability of rifampicin, isoniazid and ethambutol from a combination tablet vs. concomitant administration of a capsule containing rifampicin and a tablet containing isoniazid and ethambutol

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...

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Bibliographic Details
Published inArzneimittel-Forschung Vol. 45; no. 11; p. 1236
Main Authors Schall, R, Müller, F O, Duursema, L, Groenewoud, G, Hundt, H K, Middle, M V, Mogilnicka, E M, Swart, K J
Format Journal Article
LanguageEnglish
Published Germany 01.11.1995
Subjects
Adolescent
Adult
Antibiotics, Antitubercular - administration & dosage
Antibiotics, Antitubercular - pharmacokinetics
Antitubercular Agents - administration & dosage
Antitubercular Agents - pharmacokinetics
Biological Availability
Capsules
Cross-Over Studies
Drug Combinations
Ethambutol - administration & dosage
Ethambutol - pharmacokinetics
Humans
Isoniazid - administration & dosage
Isoniazid - pharmacokinetics
Male
Rifampin - administration & dosage
Rifampin - pharmacokinetics
Single-Blind Method
Tablets
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Summary: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).
ISSN:0004-4172