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This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Telapristone Acetate, Proellex 12 mg Formulation A, Telapristone Acetate, Proellex 12 mg Formulation B
Repros Therapeutics Inc.
Published on BioPortfolio: 2014-10-01T16:53:22-0400
To determine the safety of extended treatment with Proellex in women who have successfully completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. T...
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at...
The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast c...
Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study.
This multicenter, randomized, open-label, active-controlled study evaluated therapeutic equivalence, steady-state pharmacokinetics, and safety of a novel abiraterone acetate fine particle formulation ...
The objective of this work was to manufacture an enteric formulation of florfenicol (FF) using hot-melt extrusion (HME) technology and to evaluate its in vitro dissolution and in vivo pharmacokinetics...
The purpose of this study was to use statistical design of experiments to develop a stable aqueous enteric coating formulation containing stabilizing excipients, such as polyethylene glycol that can m...
C-acetate uptake could be increased in physiologic or inflammatory conditions without evidence of cancer. We report a hepatocellular carcinoma patient with sorafenib-induced metabolic acidosis, who sh...
Hydroxypropyl methylcellulose acetate succinate (HPMCAS) has been widely used in amorphous solid dispersions and as an enteric coating polymer. Under aqueous coating conditions and at elevated coating...
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 220.127.116.11.
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
An enzyme that catalyzes the formation of CoA derivatives from ATP, acetate, and CoA to form AMP, pyrophosphate, and acetyl CoA. It acts also on propionates and acrylates. EC 18.104.22.168.
An enzyme that catalyzes reversibly the phosphorylation of acetate in the presence of a divalent cation and ATP with the formation of acetylphosphate and ADP. It is important in the glycolysis process. EC 22.214.171.124.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
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...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...