Topics

CTx-1301 Comparative Bioavailability Study

2019-10-29 14:36:38 | BioPortfolio

Summary

The primary purpose of this study is to compare the bioavailability of CTx-1301 (dexmethylphenidate) to the registered listed drug, Focalin XR. In addition, this study seeks to characterize the pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.

Description

The study will comprise of a randomized, single-dose, four-sequence, four-period, in-clinic crossover study in approximately 36 adult ADHD subjects. All subjects considered eligible at Screening will proceed to tolerability test day, dosing 40 mg Focalin XR to evaluate safety and tolerability of the higher dose of d-MPH. If subject is able to safely tolerate the test dose, and meets all inclusion/exclusion criteria, they will be considered eligible for randomization into the study. All subjects will be randomized to receive four treatments throughout the course of the study; one CTx-1301 trimodal d-MPH tablet containing 6.25 mg d-MPH, one Focalin 5 mg XR capsule, one CTx-1301 50 mg tablet, and one 40 mg Focalin XR capsule. Administration of study drug will occur only on Assessment Days; no study drug will be administered during screening or unscheduled days (USVs).

The lowest and highest doses of CTx-1301 (dexmethylphenidate, 6.25 and 50 mg) were selected to bridge to the lowest and highest doses of Focalin XR (dexmethylphenidate, 5 and 40 mg) in this comparative BA study.

Study Design

Conditions

ADHD

Intervention

Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet, Dexmethylphenidate 40 Mg Oral Capsule, Extended Release, Dexmethylphenidate 50 mg Tablet

Status

Not yet recruiting

Source

Cingulate Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-29T14:36:38-0400

Clinical Trials [3510 Associated Clinical Trials listed on BioPortfolio]

Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the ...

Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo ...

Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo ...

Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

PubMed Articles [9900 Associated PubMed Articles listed on BioPortfolio]

Budget Impact Analysis of Extended-Release Phenytoin Capsules Compared With Immediate-Release Phenytoin Capsules for Epilepsy Patients in Thailand.

There was higher frequency of breakthrough seizures during immediate-release phenytoin capsule usage than during extended-release phenytoin capsule usage by epilepsy patients. This study aimed to esti...

Effects of diurnal variation and food on gastrointestinal transit of In-labeled hydrogel matrix extended release tablets and Tc-labeled pellets in humans.

The aim of this research was to characterize the effect of food ingestion and circadian rhythm on the gastrointestinal (GI) transit of two dosage forms: a hydrogel matrix extended release (ER) tablet ...

Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations.

IPX203 is an investigational oral extended-release capsule formulation of carbidopa and levodopa. The pharmacodynamics and efficacy of IPX203 were compared with immediate-release carbidopa-levodopa (I...

Quantifying the value of orally delivered biologic therapies: A cost-effectiveness analysis of oral semaglutide.

Oral semaglutide, currently in phase three clinical trials, represents the first case of an oral biologic medication for type 2 diabetes in the form of a daily capsule. It provides similar efficacy co...

Precision Printing of Customized Cylindrical Capsules with Multifunctional Layers for Oral Drug Delivery.

Advances in personalized medicine will require custom drug formulations and delivery mechanisms. Herein, we demonstrate a new type of personalized capsule comprising of printed concentric cylindrical ...

Medical and Biotech [MESH] Definitions

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Surgical procedure to relax the JOINT CAPSULE tissues in a joint that has a reduced range of motion due to CONTRACTURE or TISSUE ADHESIONS or joint deformities.

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)

Containers, packaging, and packaging materials for drugs and biological products. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.

Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.

More From BioPortfolio on "CTx-1301 Comparative Bioavailability Study"

Quick Search

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial