Manfred Wargenau
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View article: Survey Study to Identify the Maximum Acceptable Numbers of 2 mm and 3 mm Mini-Tablets for Short-, Middle-, and Long-Term Treatments in Acutely and Chronically Sick Children of Different Age Groups Below 18 Years
Survey Study to Identify the Maximum Acceptable Numbers of 2 mm and 3 mm Mini-Tablets for Short-, Middle-, and Long-Term Treatments in Acutely and Chronically Sick Children of Different Age Groups Below 18 Years Open
Background/Aims: This preference study aimed to identify the maximum number of mini-tablets of two different sizes that children and adolescents would be willing to take, and parents, nurses, and pediatricians would be willing to administe…
View article: Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study
Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study Open
Objective This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments. Methods In this open-…
View article: A Semi-Mechanistic Population Pharmacokinetic Model of Noscapine in Healthy Subjects Considering Hepatic First-Pass Extraction and CYP2C9 Genotypes
A Semi-Mechanistic Population Pharmacokinetic Model of Noscapine in Healthy Subjects Considering Hepatic First-Pass Extraction and CYP2C9 Genotypes Open
The current work is expected to facilitate the future pharmacokinetic/pharmacodynamic development of noscapine. This study was registered prior to starting at "Deutsches Register Klinischer Studien" under registration no. DRKS00017760.
View article: Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteers
Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteers Open
View article: Double‐blind, randomized, 8‐week multicenter study of the efficacy and safety of <scp>STW 5‐II</scp><i>versus</i> placebo in functional dyspepsia
Double‐blind, randomized, 8‐week multicenter study of the efficacy and safety of <span>STW 5‐II</span><i>versus</i> placebo in functional dyspepsia Open
Background and Aim Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting >4 weeks are widely lacking. We evaluated the efficacy and safety of …
View article: Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products
Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products Open
Since the acceptability of a medicine can significantly impact therapeutic outcomes, this study aimed to determine and compare the preferences of children, parents, and healthcare professionals for the most commonly used pediatric oral med…
View article: Efficacy and Safety of STW 5-II for Functional Dyspepsia Treatment: A Patient Data-Based Meta-Analysis
Efficacy and Safety of STW 5-II for Functional Dyspepsia Treatment: A Patient Data-Based Meta-Analysis Open
Introduction: Functional dyspepsia (FD) is a chronic relapsing gastroduodenal disorder with limited treatment options. Herbal products, like the six-herb combination STW 5-II, can target multiple FD gastrointestinal symptoms.…
View article: Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study Open
Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated min…
View article: Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial
Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial Open
Aims The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFpEF). To date, neither established heart failure therapies nor pulmonary vasodilators proved bene…
View article: A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population Open
View article: A composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population
A composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population Open
Introduction A medicine’s acceptability is likely to have significant impact on pediatric compliance. EMA and FDA guidance on this topic ask for investigation of acceptability. Although palatability and deglutition are denoted as elements …
View article: Blood glucose response after oral lactulose intake in type 2 diabetic individuals
Blood glucose response after oral lactulose intake in type 2 diabetic individuals Open
Blood glucose AUCbaseline_c (0-180 min) levels in mildly constipated, non-insulin dependent subjects with T2DM are not affected by the carbohydrate impurities contained in 20 g and 30 g crystal or liquid lactulose formulations.
View article: Effect on endometrial histology and pharmacokinetics of different dose regimens of progesterone vaginal pessaries, in comparison with progesterone vaginal gel and placebo
Effect on endometrial histology and pharmacokinetics of different dose regimens of progesterone vaginal pessaries, in comparison with progesterone vaginal gel and placebo Open
EudraCT number 2012-001726-95.
View article: Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study
Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study Open
The unchanged blood glucose levels after lactulose intake in healthy subjects suggest its safe use in subjects with impaired glucose tolerance.
View article: Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction
Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction Open