A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

2019-10-01 07:55:06 | BioPortfolio


The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women


This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Study Design




Lu AF11167, [14C]-Lu AF11167, Lu AF11167 MR tablet prototype formulation selected from part A


United Kingdom




H. Lundbeck A/S

Results (where available)

View Results


Published on BioPortfolio: 2019-10-01T07:55:06-0400

Clinical Trials [1536 Associated Clinical Trials listed on BioPortfolio]

Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia

A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia

Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as adde...

Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

A Study to Investigate the Pharmacokinetics of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772

This is a 2-part, single-dose study, which will be conducted in healthy male and female subjects, to assess the MR prototype coated tablet formulations of GSK2982772. Part A, is a 6-period...

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers

Part 1 - To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A ...

PubMed Articles [4801 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics and Bioequivalence of Memantine Tablet and a New Dry Syrup Formulation in Healthy Japanese Males: Two Single-Dose Crossover Studies.

Memantine hydrochloride, an N-methyl-D-aspartate receptor antagonist, is used to treat Alzheimer's disease (AD). A new dry syrup formulation containing memantine hydrochloride has been developed to im...

Prediction of tablet weight variability in continuous manufacturing.

This paper provides a method for prediction of weight variability of tablets made in rotary tablet presses as a function of material attributes and processing parameters. The goal was to be able to pr...

Formulation optimization, in vitro characterization and stability studies of sustain release tablets of Ketoprofen.

The aim of the current study was to formulate sustain release (SR) tablets of ketoprofen. Five batches (batch I -V) of matrix based ketoprofen tablet were prepared by dry granulation method using hydr...

Improving the combination of results in the ensembles of prototype selectors.

Prototype selection is one of the most common preprocessing tasks in data mining applications. The vast amounts of data that we must handle in practical problems render the removal of noisy, redundant...

PBPK model on the oral drug absorption in RYGB Bariatric patients: amoxicillin tablet and suspension.

The potential of a PBPK model to predict oral Amoxicillin bioavailability, by considering the physiological changes after "Roux-en-Y gastric bypass" (RYGB) surgery in bariatric patients, was evaluated...

Medical and Biotech [MESH] Definitions

A ubiquitous target SNARE protein that interacts with SYNTAXIN and SYNAPTOBREVIN. It is a core component of the machinery for intracellular MEMBRANE FUSION. The sequence contains 2 SNARE domains, one is the prototype for the Qb-SNARES, and the other is the prototype for the Qc-SNARES.

The introduction of error due to systematic differences in the characteristics between those selected and those not selected for a given study. In sampling bias, error is the result of failure to ensure that all members of the reference population have a known chance of selection in the sample.

A type of viscous polysaccharide that is secreted from PLANTS. It has natural properties that are useful in the formulation of ADHESIVES.

A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.

Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)

More From BioPortfolio on "A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects"

Quick Search

Relevant Topics

Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial