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A Clinical Study To Evaluate The Taste And Sensation Effects of two formulations of Nimorazole in Clinically Healthy Adults.

A Prospective, Open Label, Randomised, Comparative, Crossover Clinical Study to Evaluate the Taste and Sensation Effects of Nimorazole 200mg mouth dissolving tablet (F4 formulation) and Nimoral® 500mg tablet manufactured for DeVats (India) Private Limited, New Delhi in Clinically Healthy Adults.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004328
Enrollment
6
Registered
2014-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nimorazole mouth dissolving tablet 200mg (F4 formulation) : The new formulation which is in a mouth dispersible tablet. The tablet will be tested to check if the bitter taste will be to

Sponsors

DeVats India Private Limited
Lead Sponsor
Aurous HealthCare R and D India Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically healthy adults between the ages of 18 and 50 (both sexes) 2. Subject who understand and willing to sign informed consent document before start of any study specific assessment. 3. Subject has not participated in a similar investigation in the past four weeks.

Exclusion criteria

Exclusion criteria: 1. Subject who have known history of misplaced taste perceptions 2. Subjects who are smokers or have quit smoking within the last 6 months. 3. Subjects who are currently having or recently has upper respiratory or middle ear infections 4. Subjects who have recently undergone chemotherapy/ radiation treatment for head and neck cancers. 5. Subjects with recent surgeries to the ear, nose, throat including wisdom tooth extraction in the past 4 weeks. 6. Subjects with Olfactory disorders such as anosmia, partial anosmia, hyposmia, hyperosmia, dysosmia, phantosmia, olfactory agnosia. 7. Subjects with poor oral hygiene, mouth ulcers or other dental problems such as gingival or periodontal infections. 8. Subjects with history of thyroid imbalances. 9. Subjects who are on treatment with DMARD, anti inflammatory drugs, immunosuppresents for the past 6 months before inclusion into the trial. 10. Subjects who are planning a pregnancy, reported pregnant or lactating. 11. Subjects, who in the opinion of the Investigator are not eligible for enrollment in the study.

Design outcomes

Primary

MeasureTime frame
1. Score of 7 in the Gustatory Taste Test Questionnaire. 2. Score of 18 in the Gustatory Taste test Questionnaire â?? Rating. Timepoint: 1. Screening 2. Period 1 3. Period 2 - (After washout period of 2 hours) 0 end of study—

Secondary

MeasureTime frame
1. Score of 3 â?? 6 in the Gustatory Taste Test Questionnaire. 2. Score of 11 â?? 17 in the Gustatory Taste Test Questionnaire â?? Rating. Timepoint: 1. Screening 2. Period 1 3. Period 2 - (After washout period of 2 hours) 0 end of study—

Countries

India

Contacts

Public ContactDr VT Sriraam MBBS MD Pharmacology

Raam Poly Clinic

raampolyclinic@gmail.com9840909155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026