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Arzneimittelforschung 2009; 59(4): 191-194
DOI: 10.1055/s-0031-1296384
Analgesics · Anti-inflammatories · Antiphlogistics · Antirheumatic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Comparative Bioavailability of Two Dexamethasone Tablet Formulations in Indonesian Healthy Volunteers

Yahdiana Harahap
1   Department of Pharmacy, Faculty of Mathematic and Science, University of Indonesia, Depok, (Indonesia)
,
Lucy Sasongko
2   School of Pharmacy, Bandung Institute of Technology, Bandung, (Indonesia)
,
Budi Prasaja
3   Clinisindo Laboratories, Jakarta, (Indonesia)
,
Ega Indriati
3   Clinisindo Laboratories, Jakarta, (Indonesia)
,
Windy Lusthom
3   Clinisindo Laboratories, Jakarta, (Indonesia)
,
no-given-names Lipin
› Author Affiliations
Further Information

Publication History

Publication Date:
13 December 2011 (online)

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Abstract

Aim:

To compare the bioavailability of two dexamethasone (CAS 50-02-2) tablet formulations–4 mg Dexmethsone® tablets as test formulation and 4 mg tablets of the originator product as reference formulation.

Methods:

The study was conducted according to an open-label, randomized two-way crossover design with a one-week washout period. Twenty-four volunteers received a single dose of two tablets of the two different dexamethasone formulations. Blood samples for pharmacokinetic profiling were taken up to 24 h after drug administration in fasting condition. Plasma concentrations of dexamethasone were determined with a validated HPLC method using an ultraviolet detector. Pharmacokinetic parameters were calculated from observed plasma concentration-time profiles.

Result:

The mean AUC0–t, AUC0–∞ and Cmax were 501.61 ng • h/ml, 518.88 ng • h/ml and 98.02 ng/ml, respectively for the test formulation and 507.10 ng • h/ml, 525.20 ng • h/ml and 97.82 ng/ml, respectively, for the reference formulation. The median Tmax for both formulations was 0.75 h. Plasma elimination half-lives (t1/2) were 3.44 h (test) and 3.38 h (reference). The point estimates and 90% confidence intervals (CI) for AUC0–t, AUC0–∞ and Cmax were 98.92% (94.62–103.41%), 98.80% (94.51–103.28%) and 100.20% (91.43–109.81%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines.

Conclusion:

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

Key words

CAS 50-02-2 - Corticosteroids - Dexamethasone, bioequivalence, pharmacokinetics - Dexmethsone® - Glucocorticoids
 

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