Pharmacokinetics and bioequivalence study of a generic desloratadine tablet formulation in healthy male volunteers

Geng Chang Yeh, Shin Tarng Deng, Chin Yi Lo, Pei Shan Chiang, Cheng Huei Hsiong

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish
Pages (from-to)166-170
Number of pages5
JournalArzneimittel-Forschung/Drug Research
Volume54
Issue number3
Publication statusPublished - 2004

Fingerprint

Therapeutic Equivalency
Pharmacokinetics
Tablets
Healthy Volunteers
Plasmas
Liquid chromatography
Analysis of variance (ANOVA)
Liquid Chromatography
Cross-Over Studies
Calibration
Biological Availability
Area Under Curve
Half-Life
Rate constants
Analysis of Variance
Confidence Intervals
Pharmaceutical Preparations
desloratadine

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 journalArticle

Yeh, Geng Chang ; Deng, Shin Tarng ; Lo, Chin Yi ; Chiang, Pei Shan ; Hsiong, Cheng Huei. / Pharmacokinetics and bioequivalence study of a generic desloratadine tablet formulation in healthy male volunteers. In: Arzneimittel-Forschung/Drug Research. 2004 ; Vol. 54, No. 3. pp. 166-170.
@article{4244fd8a99d34752b7f8728645b7ea9c,
title = "Pharmacokinetics and bioequivalence study of a generic desloratadine tablet formulation in healthy male volunteers",
abstract = "The pharmacokinetic profiles and relative bioavailability of desloratadine (CAS 100643-71-8, Denosin{\circledR} 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.",
keywords = "CAS 100643-71-8, Denosin{\circledR}, bioequivalence, pharmacokinetics, Desloratadine, bioequivalence, pharmacokinetics",
author = "Yeh, {Geng Chang} and Deng, {Shin Tarng} and Lo, {Chin Yi} and Chiang, {Pei Shan} and Hsiong, {Cheng Huei}",
year = "2004",
language = "English",
volume = "54",
pages = "166--170",
journal = "Drug Research",
issn = "2194-9379",
publisher = "Thieme",
number = "3",

}

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 -