NDLI: Bioequivalence and pharmacokinetics of two 10-mg bisoprolol formulations as film-coated tablets in healthy white volunteers: a randomized, crossover, open-label, 2-period, single-dose, fasting study.

Please wait, while we are loading the content...

Year: 2017 Volume: 55 2017

Year: 2016 Volume: 54

Year: 2015 Volume: 53

Year: 2014 Volume: 52

Year: 2013 Volume: 51

Year: 2012 Volume: 50

Year: 2012 Volume: 50 Issue: 12

A case of hyperprolactinemia, probably induced by eletriptan.

Sequential interaction of phenytoin and phenobarbital with fluorouracil.

Associations between prescribing nonsteroidal anti-inflammatory drugs and the potential prescription-related problems in a primary care setting.

Assessment of the influence of severe renal impairment on the pharmacokinetics of mirodenafil in Korean male volunteers.

Bioequivalence and pharmacokinetics of two 10-mg bisoprolol formulations as film-coated tablets in healthy white volunteers: a randomized, crossover, open-label, 2-period, single-dose, fasting study.

Platelet activation markers after conversion from azathioprine to sirolimus based immunosuppression in renal transplant recipients.

The use of TNF-inhibitors in ankylosing spondylitis in Austria from 2007 to 2009 - a retrospective analysis.

A Phase I clinical trial of lodenafil carbonate, a new phosphodiesterase Type 5 (PDE5) inhibitor, in healthy male volunteers.

Pharmacokinetics of single and multiple oral doses of 5 mg linagliptin in healthy Chinese volunteers.

Year: 2012 Volume: 50 Issue: 11

Year: 2012 Volume: 50 Issue: 10

Year: 2012 Volume: 50 Issue: 9

Year: 2012 Volume: 50 Issue: 8

Year: 2012 Volume: 50 Issue: 7

Year: 2012 Volume: 50 Issue: 6

Year: 2011 Volume: 49

Year: 2010 Volume: 48

Year: 2009 Volume: 47

Bioequivalence and pharmacokinetics of two 10-mg bisoprolol formulations as film-coated tablets in healthy white volunteers: a randomized, crossover, open-label, 2-period, single-dose, fasting study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Bus-Kwasnik, Katarzyna Ksycinska, Hanna Les, Andrzej Serafin-Byczak, Krystyna Rudzki, Piotr J. Raszek, Jerzy Lazowski, Tomasz Bielak, Agnieszka Wybraniec, Andrzej
Description	Country affiliation: Poland Author Affiliation: Bus-Kwasnik K ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.)
Abstract	OBJECTIVE: The aim of the study was to investigate the bioavailability of a generic formulation of 10-mg bisoprolol film coated tablets (test) as compared to that of a branded formulation (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both formulations. METHODS: A randomized, crossover, open-label, 2-period, single-dose, comparative study was conducted in healthy white volunteers in fasting conditions. A single oral dose administration of the test or reference formulation was followed by a 14-day wash-out period. Blood samples were collected up to 60 hours after dosing. The bisoprolol concentrations in plasma samples were determined using a validated LC-MS/MS method. The formulations were considered bioequivalent if 90% CI of geometric mean ratios (test/reference) for AUC0-t, AUC0-∞ and Cmax were within the range 80.00 - 25.00%. Adverse events were monitored throughout the study based on the clinical parameters and volunteer reports. RESULTS: Healthy male and female subjects participating in the study had a median (range) age of 23 (20 - 43), weight of 68 kg (52 - 84), height of 172 cm (157 - 184), and BMI of 23.1 kg/m2 (19.3 - 24.9). The 26 consented volunteers have been included and 24 of them completed the clinical part of the study. The geometric mean test/referenceratios (90% CI) for AUC0-t, AUC0-∞ and Cmax were 104.12% (100.52 - 107.85%), 104.05% (100.49 - 107.75%) and 107.91% (103.04 - 112.99%), respectively. All 90% CI were embraced by the 80.00 - 25.00% acceptance interval. No serious adverse events were reported. A total number of 6 non-serious, moderate adverse events were registered, including headache and vomiting in one subject. CONCLUSIONS: The results of the single-dose study in healthy white volunteers indicated that the film-coated tablets of Bisocard® 10 mg manufactured by ICN Polfa Rzeszów S.A. (test formulation) are bioequivalent to those of Concor 10® manufactured by Merck KGaA (reference formulation). Both formulations were well tolerated.
File Format	HTM / HTML
ISSN	09461965
Issue Number	12
Volume Number	50
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2012-12-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Adrenergic Beta-1 Receptor Antagonists Pharmacokinetics Bisoprolol Adult Adverse Effects Chemistry, Pharmaceutical Cross-over Studies Fasting Female Humans Male Tablets, Enteric-coated Therapeutic Equivalency Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

Central Library (ISO-9001:2015 Certified)
Indian Institute of Technology Kharagpur
Kharagpur, West Bengal, India | PIN - 721302

See location in the Map
03222 282435
Mail: support@ndl.gov.in

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in