NDLI: Comparison of two marketed nifedipine modified-release formulations: an exploratory clinical food interaction study.

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

Comparative bioavailability of single-dose methylphenidate from a multilayer-release bead formulation and an osmotic system: a two-way crossover study in healthy young adults.

Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study.

Effects of fluvastatin extended-release (80 mg) alone and in combination with ezetimibe (10 mg) on low-density lipoprotein cholesterol and inflammatory parameters in patients with primary hypercholesterolemia: a 12-week, multicenter, randomized, open-label, parallel-group study.

Comparison of the effects of doxazosin and atenolol on target organ damage in adults with type 2 diabetes mellitus and hypertension in the CARDHIAC study: a 9-month, prospective, randomized, open-label, blinded-evaluation trial.

Ambulatory blood pressure-lowering effects of valsartan and enalapril after a missed dose in previously untreated patients with hypertension: a prospective, randomized, open-label, blinded end-point trial.

A case-control study of the association between polymorphisms of the endothelial nitric oxide synthase and glycoprotein IIIa genes and upper gastrointestinal bleeding in users of low-dose aspirin.

Two single-center, double-blind, randomized, placebo-controlled, phase I studies to investigate the tolerability and pharmacokinetics of CH-1504, an antifolate, in healthy male subjects.

Colistin serum concentrations after intravenous administration in critically ill patients with serious multidrug-resistant, gram-negative bacilli infections: a prospective, open-label, uncontrolled study.

Risk factors for hyperglycemia in hospitalized adults receiving gatifloxacin: a retrospective, nested case-controlled analysis.

How Connecticut primary care physicians view treatments for streptococcal and nonstreptococcal pharyngitis.

Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.

Open-label, prospective, randomized comparison of propofol and sevoflurane for laryngeal mask anesthesia for magnetic resonance imaging in pediatric patients.

Donepezil use in children and adolescents with tics and attention-deficit/hyperactivity disorder: an 18-week, single-center, dose-escalating, prospective, open-label study.

Alzheimer's disease: the specter of fragmented policy and financing.

Cardiovascular outcomes among patients newly initiating atorvastatin or simvastatin therapy: a large database analysis of managed care plans in the United States.

Use of darbepoetin alfa and epoetin alfa in clinical practice in patients with cancer-related anemia.

The effects of direct-to-consumer advertising of statins on the attainment of low-density lipoprotein cholesterol goals.

Year: 2008 Volume: 30 Issue: Supplementary C

Year: 2008 Volume: 30 Spec No

Year: 2008 Volume: 30 Pt 2

Year: 2007 Volume: 29

Comparison of two marketed nifedipine modified-release formulations: an exploratory clinical food interaction study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Wonnemann, Meinolf Schug, Barbara Anschütz, Maria Brendel, Erich De Nucci, Gilberto Blume, Henning
Description	Country affiliation: Germany Author Affiliation: Wonnemann M ( SocraTec R&D GmbH, Oberursel, Germany. meinolf.wonnemann@socratec-pharma.de)
Abstract	OBJECTIVE: The objective of this study was to compare the in vitro and in vivo characteristics of 2 nifedipine modified-release tablet formulations for once-daily dosing marketed in the European community, which were expected to be bioequivalent. METHODS: In vitro dissolution was tested at different pH values prior to the clinical part of the study. Either 1 tablet of a test formulation or of the reference formulation, both containing 30 mg nifedipine, were administered to healthy white male volunteers immediately after a high-fat breakfast in a randomized, open-label, 2-period crossover design. Plasma samples obtained over the subsequent period of 48 hours were analyzed using a validated LC-MS/MS method. Safety profile and tolerability of the study medications were assessed by analysis of adverse events obtained by vital sign measurements, electrocardiography, and clinical laboratory analysis. RESULTS: Twelve volunteers were enrolled (median age, 28.0 years [range, 21-42 years]; mean body mass index, 24.2 kg/m(2) [range, 19.3-27.0 kg/m(2)]). In vitro dissolution experiments revealed a significant pH dependency in drug release from the investigational tablets, while the reference tablets were found to have pH-independent dissolution. After oral administration of both tablet formulations in the fed state, marked differences in rate and extent of bioavailability were observed. Geometric mean of AUC(0-last)(test, 504.21 h x ng/mL; reference, 361.28 h x ng/mL) was significantly higher for the test product, with a point estimate of 140% and a corresponding 90% CI of 121% to 161%. For the comparison of Cmax values, geometric means were: test, 76.46 ng/mL; reference, 19.20 ng/mL, with a point estimate of 398% and a CI of 316% to 503%. Thus, a significant difference in rate and extent of bioavailability was observed between the 2 products. CONCLUSIONS: Although both treatments were well tolerated by all volunteers, the test and reference tablets were found to have different pharmacokinetic properties when administered after a high-fat meal.
File Format	HTM / HTML
ISSN	01492918
Issue Number	1
Volume Number	30
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2008-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Calcium Channel Blockers Administration & Dosage Pharmacokinetics Eating Nifedipine Administration, Oral Adult Area Under Curve Biological Availability Blood Cross-over Studies Delayed-action Preparations Dietary Fats Humans Hydrogen-ion Concentration In Vitro Techniques Male Solubility Tablets Journal Article Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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

Development of novel spray coated soft elastic gelatin capsule sustained release formulations of nifedipine.

Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect.

In vitro-in vivo correlation of modified release dosage form of lamotrigine.

Pharmacokinetics of a novel nifedipine and pH-sensitive N-succinyl chitosan/alginate hydrogel bead in rabbits.

Controlled release reservoir mini tablets approach for controlling the drug release of Galantamine Hydrobromide.

Development of nifedipine-loaded coated gelatin microcapsule as a long acting oral delivery.

Matrix tablets based on a carrageenan with the modified-release of sodium riboflavin 5'-phosphate.

Development and in vivo evaluation of novel monolithic controlled release compositions of galantamine hydrobromide as against reservoir technology.

Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules.

Comparison of two marketed nifedipine modified-release formulations: an exploratory clinical food interaction study.

Similar Documents

Development of novel spray coated soft elastic gelatin capsule sustained release formulations of nifedipine.

Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect.

In vitro-in vivo correlation of modified release dosage form of lamotrigine.

Pharmacokinetics of a novel nifedipine and pH-sensitive N-succinyl chitosan/alginate hydrogel bead in rabbits.

Controlled release reservoir mini tablets approach for controlling the drug release of Galantamine Hydrobromide.

Development of nifedipine-loaded coated gelatin microcapsule as a long acting oral delivery.

Matrix tablets based on a carrageenan with the modified-release of sodium riboflavin 5'-phosphate.

Development and in vivo evaluation of novel monolithic controlled release compositions of galantamine hydrobromide as against reservoir technology.

Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules.

Comparison of two marketed nifedipine modified-release formulations: an exploratory clinical food interaction study.