Abstract
The pharmacokinetic profiles and relative bioavailability of desloratadine (CAS 100643-71-8, Denosin® as test and another commercially available preparation as reference) tablets from two different pharmaceutical manufacturers were carried out. A single oral dose (10 mg/2 tablets) of desloratadine was administered to 8 healthy young Chinese males in a completely double-blind cross-over design with a two-week washout period between each dose. Plasma samples were obtained before and at various appropriate intervals after dosing up to 120 h. The plasma concentrations were then analyzed by a liquid chromatography/tandem mass spectrometric (LC/MS/MS) method. The limit of quantitation of this LC/MS/MS method was 0.05 ng/mL. The coefficients of variation of the within-day and between-day calibration curves (n = 6) range from 0.05 ng/mL to 10 ng/mL and were less than 10 %. The accuracy of this method was verified. Values for the area under the plasma concentration-time curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), elimination rate constant, half-life, oral clearance were estimated and compared for each preparation. By ANOVA, 90 % confidence interval, Mann-Whitney test, and paired t-test, the two desloratadine products can be considered bioequivalent for both the extent and the rate of absorption.
| Original language | English |
|---|---|
| Pages (from-to) | 166-170 |
| Number of pages | 5 |
| Journal | Arzneimittel-Forschung/Drug Research |
| Volume | 54 |
| Issue number | 3 |
| Publication status | Published - 2004 |
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Keywords
- CAS 100643-71-8
- Denosin®, bioequivalence, pharmacokinetics
- Desloratadine, bioequivalence, pharmacokinetics
ASJC Scopus subject areas
- Drug Discovery
- Organic Chemistry
- Chemistry(all)
- Pharmacology
Cite this
Pharmacokinetics and bioequivalence study of a generic desloratadine tablet formulation in healthy male volunteers. / Yeh, Geng Chang; Deng, Shin Tarng; Lo, Chin Yi; Chiang, Pei Shan; Hsiong, Cheng Huei.
In: Arzneimittel-Forschung/Drug Research, Vol. 54, No. 3, 2004, p. 166-170.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pharmacokinetics and bioequivalence study of a generic desloratadine tablet formulation in healthy male volunteers
AU - Yeh, Geng Chang
AU - Deng, Shin Tarng
AU - Lo, Chin Yi
AU - Chiang, Pei Shan
AU - Hsiong, Cheng Huei
PY - 2004
Y1 - 2004
N2 - The pharmacokinetic profiles and relative bioavailability of desloratadine (CAS 100643-71-8, Denosin® as test and another commercially available preparation as reference) tablets from two different pharmaceutical manufacturers were carried out. A single oral dose (10 mg/2 tablets) of desloratadine was administered to 8 healthy young Chinese males in a completely double-blind cross-over design with a two-week washout period between each dose. Plasma samples were obtained before and at various appropriate intervals after dosing up to 120 h. The plasma concentrations were then analyzed by a liquid chromatography/tandem mass spectrometric (LC/MS/MS) method. The limit of quantitation of this LC/MS/MS method was 0.05 ng/mL. The coefficients of variation of the within-day and between-day calibration curves (n = 6) range from 0.05 ng/mL to 10 ng/mL and were less than 10 %. The accuracy of this method was verified. Values for the area under the plasma concentration-time curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), elimination rate constant, half-life, oral clearance were estimated and compared for each preparation. By ANOVA, 90 % confidence interval, Mann-Whitney test, and paired t-test, the two desloratadine products can be considered bioequivalent for both the extent and the rate of absorption.
AB - The pharmacokinetic profiles and relative bioavailability of desloratadine (CAS 100643-71-8, Denosin® as test and another commercially available preparation as reference) tablets from two different pharmaceutical manufacturers were carried out. A single oral dose (10 mg/2 tablets) of desloratadine was administered to 8 healthy young Chinese males in a completely double-blind cross-over design with a two-week washout period between each dose. Plasma samples were obtained before and at various appropriate intervals after dosing up to 120 h. The plasma concentrations were then analyzed by a liquid chromatography/tandem mass spectrometric (LC/MS/MS) method. The limit of quantitation of this LC/MS/MS method was 0.05 ng/mL. The coefficients of variation of the within-day and between-day calibration curves (n = 6) range from 0.05 ng/mL to 10 ng/mL and were less than 10 %. The accuracy of this method was verified. Values for the area under the plasma concentration-time curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), elimination rate constant, half-life, oral clearance were estimated and compared for each preparation. By ANOVA, 90 % confidence interval, Mann-Whitney test, and paired t-test, the two desloratadine products can be considered bioequivalent for both the extent and the rate of absorption.
KW - CAS 100643-71-8
KW - Denosin®, bioequivalence, pharmacokinetics
KW - Desloratadine, bioequivalence, pharmacokinetics
UR - http://www.scopus.com/inward/record.url?scp=1642353041&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=1642353041&partnerID=8YFLogxK
M3 - Article
C2 - 15112863
AN - SCOPUS:1642353041
VL - 54
SP - 166
EP - 170
JO - Drug Research
JF - Drug Research
SN - 2194-9379
IS - 3
ER -