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 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).
Schall
R
R
Farmovs Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Bloemfontein, Republic of South Africa.
Müller
F O
FO
Duursema
L
L
Groenewoud
G
G
Hundt
H K
HK
Middle
M V
MV
Mogilnicka
E M
EM
Swart
K J
KJ
D000293:Adolescent; D000328:Adult; D000904:Antibiotics, Antitubercular / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D004338:Drug Combinations; D004977:Ethambutol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D012293:Rifampin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016037:Single-Blind Method; D013607:Tablets
D000904:Antibiotics, Antitubercular; D000995:Antitubercular Agents; D002214:Capsules; D004338:Drug Combinations; D013607:Tablets; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin