Emesis Clinical Trial
Official title:
A New Dual Function Oro-Dissolvable/Dispersible Meclizine HCL Tablet to Challenge Patient Inconvenience: In-Vitro Evaluation and In-Vivo Assessment in Human Volunteers
The main goal of this study is to develop a new oro-dissolvable/dispersible tablet that will augment the dual rapid absorption of MCZ from the buccal cavity as well as prolonging that from the GIT. A dual function tablet is expected to encompass an outer coat of the drug with special excipients that will rapidly disperse and the drug get dissolve and absorb in the buccal cavity and an inner core that will similarly, disperse to release MCZ coated nanoparticles in the saliva. The latter will be subsequently swallowed without water to be absorbed in a prolonged manner from the GIT. This will be advantageous for geriatric as well as pediatric patients, besides, those suffering from dysphagia. The pharmacokinetics profile of the prepared dual function tablet will be assessed in human volunteers through noncompartmental analysis.
The oral route is the most advantageous one for delivering drugs due to patient compliance
and its convenient administration. Fast disintegrating drug delivery systems are those that
disintegrate immediately in the buccal cavity liberating the drug which dissolves or
disperses in the saliva without need of water. The European Pharmacopeia adopted
oro-dispersible tablets (ODT) for a tablet that disintegrate or disperse in less than 60 sec
in the buccal cavity before swallowing. So, the drug dissolution and absorption in addition
to onset of clinical influence and drug bioavailability may be considerably better than those
detected from conventional tablets and capsules. ODTs were initially industrialized to
increase the patient compliance (children, geriatric and bedridden patients).
Nanoparticulate delivery systems have been investigated widely in the pharmaceutical industry
owing to protection from degradation in GIT, the ability to control release of drugs and
improvement of bioavailability.
Meclizine HCL, an antihistamine, has been widely used for prophylactic treatment of nausea,
vomiting and management of dizziness accompanying motion sickness. MCZ is commonly used due
to fewer adverse effects than other antihistaminic drugs but its onset of action is about 1 h
and possesses short half-life. MCZ is a poor water soluble drug and associated with slow rate
of absorption from oral route, therefore, there is a need to improve its dissolution and so
ensure the maximum therapeutic utility. However, many different formulations of MCZ have been
investigated to improve its overall solubility in order to enhance its bioavailability, such
as; complexation with cyclodextrin, preparation of solid dispersions as oro- dispersible
tablets and fast dissolving tablet by sublimation method. Moreover, authors will investigate
the ability of floating microspheres to increase the half-life of MCZ
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01913990 -
Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.
|
Phase 4 | |
Terminated |
NCT00869310 -
Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis
|
Phase 3 | |
Terminated |
NCT00869973 -
Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients
|
Phase 3 | |
Completed |
NCT04719286 -
MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy
|
N/A | |
Completed |
NCT01046240 -
Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy
|
Phase 1/Phase 2 | |
Recruiting |
NCT03478605 -
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
|
Phase 2 | |
Terminated |
NCT01148264 -
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
|
Phase 2 | |
Completed |
NCT01509417 -
Different Feeding Methods After Pyloromyotomy
|
N/A | |
Completed |
NCT00152867 -
Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy
|
Phase 3 | |
Completed |
NCT04182750 -
Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
|
N/A | |
Completed |
NCT02980289 -
DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
|
||
Completed |
NCT02602080 -
Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
|
||
Completed |
NCT04585841 -
The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy
|
Phase 1 | |
Completed |
NCT01414478 -
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
|
N/A | |
Not yet recruiting |
NCT02407600 -
Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy
|
Phase 2 |