A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers

Prasaja, Budi; Harahap, Yahdiana; Lusthom, Windy; Setiawan, Evy C.; Ginting, Mena Bertony; Hardiyanti,; Lipin,

doi:10.1007/s13318-011-0033-1

Cited by 5 publications

(2 citation statements)

References 4 publications

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“…[15] This result supports the linear PK characteristics of tamsulosin. [2] The test drug formulation we investigated was a SR tablet for once daily dosing.…”

Section: Discussionsupporting

confidence: 76%

Bioequivalence of the pharmacokinetics between two formulations of 0.2 mg tamsulosin hydrochloride in healthy subjects

Park

Rhee

Jang

et al. 2015

Transl Clin Pharmacol

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Tamsulosin is an effective therapeutic option for lower urinary tract symptoms, as it selectively blocks α1A-and α1D-adrenoceptors in the bladder and prostate. The purpose of this study was to evaluate the bioequivalence in the pharmacokinetics (PK) of two 0.2 mg tamsulosin formulations when administered as the reference formulation (Yuropa® sustained-release tablet) vs. the test formulation (Yutanal® capsule) in healthy male subjects. A randomized, open-label, single-dose, twoway, two-period, crossover study was conducted in 37 healthy volunteers. The 0.2 mg of tamsulosin as the test or the reference formulation were administered during each period, and serial blood samples were collected up to 36 hours after dosing for PK analyses. A non-compartmental analysis was used to estimate the PK parameters. Geometric mean ratios (GMR) and 90% confidence intervals (CIs) were calculated for the two formulations to compare the maximum concentration (C max ) and the area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC last ). The mean C max and AUC last for the test formulation were 6.19 μg/L and 71.30 μg.h/L, respectively, and 5.76 μg/L and 70.38 μg.h /L for the reference formulation, respectively. The GMRs (90% CIs) of the C max and AUC last between the two formulations were 1.09 (1.01-1.17) and 1.03 (0.96-1.10), respectively. Tamsulosin 0.2 mg as the test formulation exhibited bioequivalent PK profiles to those of the reference formulation. Therefore, the test formulation is expected to be an alternative to the reference formulation without concerns about differences in drug exposure.

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“…[15] This result supports the linear PK characteristics of tamsulosin. [2] The test drug formulation we investigated was a SR tablet for once daily dosing.…”

Section: Discussionsupporting

confidence: 76%

Bioequivalence of the pharmacokinetics between two formulations of 0.2 mg tamsulosin hydrochloride in healthy subjects

Park

Rhee

Jang

et al. 2015

Transl Clin Pharmacol

View full text Add to dashboard Cite

show abstract

“…Sample size was determined on the basis of the withinsubject variability of tamsulosin C max (%CV = 26.38), 13 considering a 2-way crossover design. The estimation was performed considering the following parameters: 1 − β = 0.8, α = 0.05, and an equivalence range of 80% to 125%.…”

Section: Sample Sizementioning

confidence: 99%

Bioequivalence Assessment of an Oral Fixed‐Dose Formulation of Dutasteride‐Tamsulosin 0.5 mg/0.4 mg: A Randomized, Single‐Blind, Single‐Dose, 2‐Period Crossover Study in Mexican Population Under Fasted Conditions

Piñeyro-Garza¹,

Gómez-Silva²,

Gamino³

et al. 2021

Clinical Pharm in Drug Dev

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The aim of the present study was to compare the bioavailability and to demonstrate the bioequivalence between a dutasteride-tamsulosin 0.5 mg/0.4 mg capsule formulation and the regulatory reference drug (Combodart®, Glaxo-SmithKline). A randomized, single-blind, single-dose, 2-way crossover study under fasting conditions, with at least a 28-day washout period was carried out in healthy volunteers. Plasma concentrations of drugs were determined by high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic analysis included maximum plasma concentration (C max ), area under the plasma concentration-time curve (AUC) from time 0 to 72 hours, and AUC from baseline to infinity. The test formulation was considered bioequivalent if the geometric mean ratios (test/reference) were within the predetermined range of 80% to 125%. Safety and tolerability were evaluated by clinical assessment. The confidence intervals for the log-transformed test/reference ratios for dutasteride, C max (95.4-109.2) and AUC from baseline to 72 hours (93.2-109.1), and for tamsulosin, C max (101.9-119.8), AUC from baseline to the last quantifiable concentration (91.4-106.3) and AUC from baseline to infinity (90.9-103.3), were within the allowed limit specified by the regulatory authorities (80%-125%). In addition, both test and reference drugs were safe and tolerated. These results demonstrated the bioequivalence of test product (Dakart®) compared with Combodart®.

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Effects of Schisandra chinensis extract on the relaxation of isolated human prostate tissue and smooth muscle cell

Choo

Sung

Chae

et al. 2014

Journal of Ethnopharmacology

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A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers

Cited by 5 publications

References 4 publications

Bioequivalence of the pharmacokinetics between two formulations of 0.2 mg tamsulosin hydrochloride in healthy subjects

Bioequivalence of the pharmacokinetics between two formulations of 0.2 mg tamsulosin hydrochloride in healthy subjects

Bioequivalence Assessment of an Oral Fixed‐Dose Formulation of Dutasteride‐Tamsulosin 0.5 mg/0.4 mg: A Randomized, Single‐Blind, Single‐Dose, 2‐Period Crossover Study in Mexican Population Under Fasted Conditions

Effects of Schisandra chinensis extract on the relaxation of isolated human prostate tissue and smooth muscle cell

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