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Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers

หน่วยงาน มหาวิทยาลัยเชียงใหม่

รายละเอียด

ชื่อเรื่อง : Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers
นักวิจัย : Rojanasthien N. , Nasangiam N. , Kumsorn B. , Roongapinun S. , Jengjareon A.
คำค้น : -
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2551
อ้างอิง : 01252208 , 18672641 , JMTHB , http://www.scopus.com/inward/record.url?eid=2-s2.0-44649146524&partnerID=40&md5=2808df279c098ae3309a4a187cae5ce9 , http://www.ncbi.nlm.nih.gov/pubmed/18672641 , http://cmuir.cmu.ac.th/handle/6653943832/2441
ที่มา : -
ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
บทคัดย่อ/คำอธิบาย :

Objective: To determine the pharmacokinetics and bioequivalence of two 20-mg quinapril hydrochloride tablet preparations; Quinaril® (The Biolab Ltd, Bangkok, Thailand) as the test and Accupril® as the reference. Material and Method: The present study was a single dose, randomized, two-period crossover design conducted in 24 healthy volunteers under fasting conditions with a 7-day washout period. Serial plasma concentrations of quinapril and its active metabolite quinaprilat up to 24 h after dosing were determined by HPLC with UV detection. The pharmacokinetic parameters were analyzed by noncompartmental analysis and the ANOVA was carried out using logarithmically transformed data of the AUC and Cmax as well as untransformed T max. Results: There were no significant differences between the two preparations regarding the Tmax of quinapril and quinaprilat and their median Tmax were 0.5 h and 1.4 - 1.5 h, respectively. The half-life of quinapril (1.2 h) was faster than quinaprilat (1.8-1.9 h) although the volume of distribution (Vd/F) of quinapril (1.1 L/kg) was larger than quinaprilat (0.3 L/kg), however, its clearance rate (CL/F) was faster when compared to quinaprilat (20-26 ml/min/kg vs. 1.7 ml/min/kg). The mean (90% CI) for the ratios Test/Reference of quinapril were 0.99 (0.89-1.10), 0.99 (0.90-1.09) and 1.01 (0.90-1.14), respectively for AUC0-24, AUC 0-∞ and Cmax. Similarly, the corresponding values for quinaprilat were 0.95 (0.90-1.01), 0.95 (0.90-1.01) and 1.03 (1.00-1.07), respectively. These values were within the bioequivalence range of 0.80 - 1.25, thus, demonstrated the bioequivalence of the two preparations. Conclusion: The results of the present study indicated that the two quinapril HCL preparations are bioequivalent and it can be assumed that they are therapeutically equivalent and exchangeable in clinical practice.

บรรณานุกรม :
Rojanasthien N. , Nasangiam N. , Kumsorn B. , Roongapinun S. , Jengjareon A. . (2551). Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers.
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Rojanasthien N. , Nasangiam N. , Kumsorn B. , Roongapinun S. , Jengjareon A. . 2551. "Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers".
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Rojanasthien N. , Nasangiam N. , Kumsorn B. , Roongapinun S. , Jengjareon A. . "Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers."
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ , 2551. Print.
Rojanasthien N. , Nasangiam N. , Kumsorn B. , Roongapinun S. , Jengjareon A. . Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers. เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ ; 2551.