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Effect of Indinavir on the Single‐Dose Pharmacokinetics of Theophylline in Healthy Subjects
Author(s) -
Mistry Goutam C.,
Laurent Aziz,
Sterrett Andrew T.,
Deutsch Paul J.
Publication year - 1999
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912709922008146
Subject(s) - theophylline , indinavir , pharmacokinetics , placebo , medicine , pharmacology , crossover study , drug interaction , bronchodilator , oral administration , human immunodeficiency virus (hiv) , sida , immunology , asthma , alternative medicine , pathology , viral disease
The effect of multiple doses of indinavir on the pharmacokinetics of a single dose of theophylline was investigated in 16 healthy male subjects using a randomized, double‐blind, placebo‐controlled, parallel‐group study design. On days 1 and 7, all of the subjects received a single oral 250 mg dose of theophylline. From days 2 to 7, the subjects received orally administered 800 mg doses of indinavir or a matched placebo every 8 hours. On day 7, theophylline and indinavir (or a placebo) were coadministered. The geometric mean AUC (0–24 h) of theophylline increased 18% when coadministered with indinavir compared to when theophylline was administered alone. This small increase in AUC (0–24 h) , although considered statistically significant, did not meet the prespecified criterion for clinical significance. The geometric mean C max of theophylline, when coadministered with indinavir, was within 8% of theophylline when administered alone. The mean t max (± SD) value for theophylline, when coadministered with indinavir (0.9 ± 0.5 h), was comparable to that observed for theophylline alone (1.0 ± 0.5 h). In conclusion, the administration of multiple doses of indinavir followed by a single dose of theophylline did not appear to result in a clinically significant pharmacokinetic interaction for theophylline.