Supriya DESHPANDE
(Vidyabharati College of Pharmacy, Amravati, India)
Vivek Vijayrao PAİTHANKAR
(Vidyabharati College of Pharmacy, Amravati, India)
Yıl: 2013Cilt: 10Sayı: 2ISSN: 1304-3889 / 1304-3897Sayfa Aralığı: 83 - 89Türkçe

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A Comparative single dose bioequivalence study of extended release antihypertensive drug formulation among healthy human volunteers
Bu çalışmanın amacı, biyolojik olarak eşdeğer olması beklenen, günde bir defalık diltiazem uzatılmış salınım formülasyonlarının in vivo özellikleri karşılaştırmaktı. Her ikisi de 360 mg Diltiazem ihtiva eden bir test formülasyonun iki kapsülü veya refer- ans formülasyonun 1 kapsülü, on saat aç bekletildikten sonra sağlıklı erkek gönüllülere randomize, açık etiketli, üç periyotlu çapraz tasarımda verilmiştir. Üzerinden 72 saat süre geçtikten sonra elde edilen Plazma numuneleri geçerli bir LC-MS/MS yöntemi kullanılarak analiz edildi. Çalışma ilaçlarının güvenlik profili ve tolere edilebilirliği vital bulguların ölçümü, elektrokardiyografi ve klinik ile elde edilen yan etkilerin analizi ile değerlendirildi. Cmax log dönüştürülmüş verileri için 90% CI, AUC0-t,AUC0-∞ her iki ilaç için dar terapötik indeks ilaçlar için biyoeşdeğerliliğin öngörülen limitleri içine düştü, örneğin 80- 120%. Bu tek doz çalışma tespit etmiştir ki test ve referans ürünler açlık altında sağlıklı, erkek gönüllülerde biyoeşdeğerlik için düzenleyici kriterleri karşılamaktadır.
Fen > Tıp > Cerrahi
DergiAraştırma MakalesiErişime Açık
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