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Evaluation of Meclizine Orodispersible Tablet Pharmacokinetic in Human Volunteers

NCT04564144 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Emesis

Interventions

DRUG

Meclizine Hydrochloride

A study will be conducted on the three tested orodispersible tablets and the commercial one (control). 6 volunteers are asked to cease any medication 7 days prior to blood sampling at least. Each volunteer will undergo 4 study sessions with one week of washout period in between (cross-overed to receive the other formulation). All volunteers are asked to fast overnight before taking the tablet. The tablet should be kept for 10 min in the mouth before swallowing without water. Just before taking the tablet, three milliliters of venous blood samples will be drown (predose, 0 h) and at 30, 60, 90, 120, 240, 360, 480, 720 min and 24 h postdose and stored in tubes coated with sodium heparin. Separation of plasma from Blood samples will be carried out by centrifuging at 5000 rpm for 10 min, then, it will be frozen at -20°C until analysis. By employing high-performance liquid chromatography (HPLC), the plasma concentration of MCZ will be assayed

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Alaa Y. Darwesh, Dr · Mansoura University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-11-01
Completion
2020-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04564144 on ClinicalTrials.gov