BE STUDY OF AVOMINE MOUTH DISSOLVING TABLET IN HEALTHY HUMAN MALE SUBJECTS

Phase 1

Completed

• Registration Number: CTRI/2018/06/014352
• Lead Sponsor: Abbott Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

a) Non smoker, non-alcoholic, healthy adult human male subjects between 18 and 45 years of age

(both inclusive) living in and around Ahmedabad city or western part of India.

b) Having a Body Mass Index (BMI) between 18.5 and 30 (both inclusive), calculated as weight in kg/ height in meter sqaure.

c) Subject weight should be more than 50 kg at the time of screening.

d) Not having any significant diseases or clinically significant abnormal findings during screening,

medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest

(Postero-anterior view) recordings.

e) Able to understand and willing to comply with the study procedures, in the opinion of the Principal

investigator.

f) Subjects who are able and willing to give written informed consent.

Exclusion Criteria

a) Known hypersensitivity or idiosyncratic reaction to Promethazine or any other similar/ related

drugs.

b) History or presence of any disease or condition which might compromise the haemopoietic, renal,

hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,

gastrointestinal or any other body system.

c) Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats

per minute at the time of screening

d) Presence of orthostatic hypotension at screening.

e) History of major surgery within 4 weeks prior to receiving study medicine in period-I.

f) Ingestion of a medication (including prescribed and/or non-prescribed, systemic and/or topical

medication including herbal supplements/medicines) from 14 days prior to dosing of Period-I. In

any such case subject selection will be at the discretion of the Principal Investigator.

g) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs

induced urticaria.

A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more

than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine

or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or

alcoholic products within 48 hours prior to receiving study medicine in period-I.

i) Smokers, or who have smoked within last six months prior to start of the study.

j) Consumption of grapefruit or grapefruit products within a period of 72 hours prior to dosing in period-I.

k) The presence of clinically significant abnormal laboratory values during screening.

l) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug

scans.

m) History or presence of psychiatric disorders.

n) A history of difficulty in donating blood.

o) Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or

participation in a drug research study within 90 days prior to receiving the first dose of study

medicine. Elimination half-life of the study drug should be taken into consideration for inclusion

of the subject in the study.

Note: In case the blood loss was less than or equal to 200 mL; subject may be enrolled 60 days

after blood donation or after the last sample of previous study.

p) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.

q) A positive test result for HIV (I & II) antibody.

r) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IMP

in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.

s) Difficulty in swallowing tablets or other oral solid dosage forms.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate bioequivalence after single oral administration of <br/ ><br>test product versus single oral administration of reference product under fasting conditions in <br/ ><br>healthy adult human male subjects.Timepoint: Pre-dose- 11 hours <br/ ><br>Post-dose- 24 hours <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Promethazine theoclate following single oral administration of test product versus single oral administration of reference product in healthy adult human male subjects.Timepoint: Pre-dose- 11 hours <br/ ><br>Post-dose- 24 hours <br/ ><br>