Comparative Bioavailability of Two Dexamethasone Tablet Formulations in Indonesian Healthy Volunteers

Harahap, Yahdiana; Sasongko, Lucy; Prasaja, Budi; Indriati, E.; Lusthom, Windy; Lipin,

doi:10.1055/s-0031-1296384

Cited by 2 publications

(2 citation statements)

References 2 publications

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“…Additionally, we compared the AUC(0-t) and Cmax from our study with previously published PK data. Following a PubMed search, we found eight human studies reporting AUC(0-t) and Cmax for orally administered dexamethasone doses between 0.5 mg and 300 mg.[ 12 – 19 ] Although two of these studies [ 12 , 18 ] reported deviating results for various reasons, overall, it was concluded that the pharmacokinetics of oral dexamethasone show linearity and that the AUC and Cmax obtained for Fortecortin (and Dexa ODF) in the current study fit in with current literature.…”

Section: Discussionsupporting

confidence: 60%

Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone tablets

Diamant

Palmgren

Westrin

et al. 2017

European Clinical Respiratory Journal

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Introduction: Systemic corticosteroids are anti-inflammatory agents with dexamethasone among the most potent in the class. Within (respiratory) allergy, systemic corticosteroids are usually applied in medical emergencies. In these situations, patients may experience physical or logistic problems taking tablets. To fulfil a practical unmet need for outpatients, Dexa ODF, an oral dissolvable film containing dexamethasone, was developed.Objectives: We compared the safety, tolerability and pharmacokinetics (PK) of Dexa ODF with Fortecortin tablets in healthy subjects.Methods: Thirty subjects participated in this open label, two-way, cross-over study, consisting of two treatment visits separated by 5–10 days. On both treatment visits, subjects randomly received one single dose of Dexa ODF (one strip; 8 mg dexamethasone) or one single dose of Fortecortin (two 4 mg tablets). Safety evaluations and blood sampling for PK were conducted until 48 h post-dose and bioequivalence analysis was performed on AUC(0-t), AUC(0-∞) and Cmax.Results: All subjects were dosed. Forty-five adverse events (AEs) were reported by 17 subjects and approximately 50% were deemed ‘possibly treatment related’ (14 on Dexa ODF; 12 on Fortecortin) with no significant difference between treatments. For all three bioequivalence parameters the 90% CIs were within the acceptance limits of bioequivalence (0.8;1.25).Conclusion: We demonstrated good tolerability and bioequivalence of Dexa ODF (8 mg dexamethasone) compared to Fortecortin tablets (2 × 4 mg dexamethasone). Dexa ODF is currently under development as an innovative treatment for use within respiratory and allergic conditions, including emergencies.

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Section: Discussionsupporting

confidence: 60%

Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone tablets

Diamant

Palmgren

Westrin

et al. 2017

European Clinical Respiratory Journal

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“…Dexamethasone serum concentrations were determined by a reversed phase HPLC method, with ultraviolet detection at 240 nm, according to the method described by Harahap et al . Using 1 ml of serum the limit of quantification was 2.5 μg l −1 . The within run precision expressed as the relative standard deviation varied between 2.6% and 1.5% at concentrations between 15 and 85 μg l −1 .…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community‐acquired pneumonia

Spoorenberg

Deneer

Grutters

et al. 2014

Brit J Clinical Pharma

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AIMThe use of corticosteroids as adjunctive therapy might be effective in patients with community-acquired pneumonia (CAP). Oral administration of dexamethasone is a practical and safer alternative to the intravenous route. Since patients hospitalized with pneumonia might have delayed gastric emptying, this study explored systemic exposure in terms of area under the concentration-time curve (AUC) of oral dexamethasone in patients hospitalized with CAP. METHODSIn this randomized, open label study, 30 patients admitted with CAP were randomized to receive either 4 mg intravenous or 6 mg oral dexamethasone for 4 consecutive days. Serial blood samples were obtained before and after drug administration. RESULTSMedian AUC to infinity was 626 μg l −1 h (IQR 401-1161) for the intravenous group and 774 μg l −1 h (IQR 618-1146) for the oral group. The AUC ratio of 6 mg oral and 4 mg intravenous dexamethasone was 1.22 (95% confidence interval (CI) 0.81, 1.82), which represents a bioavailability of 81% (95% CI 54, 121) after correction for differences in dexamethasone dose.

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Comparative Bioavailability of Two Dexamethasone Tablet Formulations in Indonesian Healthy Volunteers

Abstract: These results indicate that the two formulations of dexamethasone are bioequivalent and thus may be prescribed interchangeably.

Cited by 2 publications

References 2 publications

Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone tablets

Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone tablets

Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community‐acquired pneumonia

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