Comparative Pharmacokinetics of Morning and Evening Doses of Once-a-Day Theophylline Capsules

Harrison, Lester I.; Kehe, Colin R.; Ekholm, Bruce P.; Chang, Shaw F.; Lavoie, Kim A.; Kisicki, James C.

doi:10.1002/jps.2600830818

Cited by 3 publications

(3 citation statements)

References 38 publications

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“…The results of the present study demonstrate that donepezil does not alter the pharmacokinetic or safety profile of sustained‐release theophylline in healthy volunteers. The larger values of C max and AUC (0–12) and the smaller value of t max seen after the morning dose of theophylline reflect previously reported diurnal variation between morning and evening doses [ 19].…”

Section: Discussionsupporting

confidence: 73%

Concurrent administration of donepezil HCl and theophylline: assessment of pharmacokinetic changes following multiple‐dose administration in healthy volunteers

Tiseo

Friedhoff

1998

Brit J Clinical Pharma

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Aim The aim of the study was to evaluate the pharmacokinetics of theophylline administered alone, and in combination with donepezil HCl, following multiple‐dose administration of both drugs in healthy volunteers. Methods This was an open‐label, randomized, two‐period crossover study in healthy male volunteers (n=12). During each treatment period, subjects received either titrated‐dose theophylline alone, or in combination with donepezil (5 mg, once daily) for 10 consecutive days. On day 10 of each treatment period, serial blood samples for the determination of theophylline concentrations in plasma were measured up to 24 h. Treatment periods were separated by a 3‐week, drug‐free washout. Plasma concentrations of theophylline were determined by HPLC with UV detection. Results No statistically significant differences in theophylline pharmacokinetics (Cmax, AUC or tmax ) were observed between theophylline administered alone and in combination with donepezil. No clinically significant changes in vital signs, ECG parameters or clinical laboratory tests were observed in any subject during any treatment period. Conclusions Concurrent administration of donepezil HCl does not alter the pharmacokinetic profile of theophylline following multiple‐dose administration of both drugs in healthy volunteers. These findings suggest that donepezil may be safely co‐administered with theophylline without a need for dose modification or additional monitoring procedures.

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Section: Discussionsupporting

confidence: 73%

Concurrent administration of donepezil HCl and theophylline: assessment of pharmacokinetic changes following multiple‐dose administration in healthy volunteers

Tiseo

Friedhoff

1998

Brit J Clinical Pharma

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“…The NASAL-7 and NASAL-3 were validated against the University of Pennsylvania Smell Identification Test (UPSIT). In the UPSIT, scores out of 40 correspond to categories of OD including normosmia (≥34 in males, ≥35 in females), mild hyposmia (30-33 in males, 31-34 in females), moderate hyposmia (26-29 in males, 26-30 in females), severe hyposmia (19)(20)(21)(22)(23)(24)(25), anosmia (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18), and malingering (≤5). A cutoff of 7/14 on the NASAL-7 was optimal for classifying patients as having at least moderate hyposmia on UPSIT versus not, with 79% sensitivity (95% confidence interval [CI]: 66%-89%), 70% specificity (95% CI: 58%-80%), and area under the receiver operating characteristic curve [AUC] 0.814 (95% CI: 0.727-0.900).…”

Section: Outcome Measure Development Clinical Global Impressions (Cgi...mentioning

confidence: 99%

“…The maximum daily dose tested was 800 mg to stay below 900 mg, which was among the highest daily oral doses of theophylline used in a published study. 23 Daily nasal irrigations with 800 mg theophylline correspond to a systemic daily dose of 20 mg, which is much lower than the starting oral dose of 300 mg when used for pulmonary disorders. | 133…”

Section: Scent Trialsmentioning

confidence: 99%

Clinical studies in COVID‐related olfactory disorders: Review of an institutional experience

Tharakan,

Kallogjeri,

Piccirillo

2024

World j. otorhinolaryngol.-head neck surg.

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ObjectiveTo share a single institutional experience with clinical research on COVID‐related olfactory dysfunction (OD).Data Source/MethodNarrative review of published original data and ongoing clinical trials on COVID‐related OD at Washington University from 2020 to 2023.ResultsThere were three new diagnostic‐/patient‐reported outcome measures developed and tested. We report five clinical trials of interventions for COVID‐related olfactory disorders: combined Visual‐Olfactory Training (VOLT) with patient‐preferred scents versus standard olfactory training (VOLT trial), oral gabapentin versus placebo (Gabapentin for the Relief of Acquired Chemosensory Experience trial), nasal theophylline irrigations versus placebo (Smell Changes and Efficacy of Nasal Theophylline trial), stellate ganglion block (single‐arm), and mindfulness‐based stress reduction (MBSR) versus lifestyle intervention (MBSR trial).ConclusionsInitial intervention trials for COVID‐related OD have shown potential for improving subjective and objective olfactory outcomes. However, there remains no gold standard treatment that definitively outperforms placebo in controlled trials. Therefore, continued investigation of novel therapeutic strategies for COVID‐related OD is necessary to maximize olfactory outcomes for affected patients.

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Minimizing Bioavailability Variations with Oral Controlled Release Formulations

Kaushal

Garg

2003

American Journal of Drug Delivery

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Comparative Pharmacokinetics of Morning and Evening Doses of Once-a-Day Theophylline Capsules

Cited by 3 publications

References 38 publications

Concurrent administration of donepezil HCl and theophylline: assessment of pharmacokinetic changes following multiple‐dose administration in healthy volunteers

Concurrent administration of donepezil HCl and theophylline: assessment of pharmacokinetic changes following multiple‐dose administration in healthy volunteers

Clinical studies in COVID‐related olfactory disorders: Review of an institutional experience

Minimizing Bioavailability Variations with Oral Controlled Release Formulations

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