| CTRI Number |
CTRI/2018/06/014352 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Bioequivalence Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
BE STUDY OF AVOMINE MOUTH DISSOLVING TABLET IN HEALTHY HUMAN MALE SUBJECTS |
|
Scientific Title of Study
|
AN OPEN-LABEL, BALANCED, RANDOMIZED, TWO-PERIOD, TWO-SEQUENCE, TWOTREATMENT CROSS-OVER BIOEQUIVALENCE STUDY OF TEST PRODUCT AVOMINE MD (PROMETHAZINE THEOCLATE ORALLY DISINTEGRATING TABLET 25 MG) VERSUS REFERNCE PRODUCT AVOMINE® UNCOATED TABLETS (25 MG) UNDER FASTING CONDITIONS IN HEALTHY HUMAN MALE SUBJECTS |
| Trial Acronym |
PRTE1001 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| version:2; dated 17-10-2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Adarsh Garg |
| Designation |
Senior Manager - Clinical Pharmacology & Medical Affairs |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Clinical Department, Lambda Therapeutic Research Ltd Lambda house
Plot no.38
Survey no388
Near Silver Oak Club
S. G. Highway
Gota
Ahmedabad 382481 Gujarat
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202504 |
| Fax |
|
| Email |
adarshgarg@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Adarsh Garg |
| Designation |
Senior Manager - Clinical Pharmacology & Medical Affairs |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Clinical Department, Lambda Therapeutic Research Ltd Lambda house
Plot no.38
Survey no388
Near Silver Oak Club
S. G. Highway
Gota
Ahmedabad 382481 Gujarat
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202504 |
| Fax |
|
| Email |
adarshgarg@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director, Clinical Operations and Pharmacovigilance |
| Affiliation |
Abbott Healthcare Pvt. Ltd. |
| Address |
Department: Clinical Operations, Medical Affairs, Floor 16, Godrej BKC, Plot No. C68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02238160918 |
| Fax |
|
| Email |
shubhangi.desai@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adarsh Garg |
Lambda Therapeutic Research Ltd |
Lambda house, Plot no. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad - 382481, Gujarat, India.
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
07940202504
adarshgarg@lambda-cro.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anveshhan Independent Ethics Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult human male subjects between 18 and 45 years of age
(both inclusive) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Avomine MD (Promethazine Theoclate Mouth Dissolving Tablets 25 mg) |
Avomine MD (Promethazine Theoclate Mouth Dissolving Tablets 25 mg)Each MD (Orally Disintegrating) tablets contains:
Promethazine Theoclate I.P. 25 mg
Duration of therapy: Post dose 24 hour housing in each study period
Manufactured By: Abbott Healthcare Pvt. Ltd., India. |
| Comparator Agent |
Avomine® Tablets (Promethazine Theoclate Tablets I.P.) 25 mg |
Avomine® Tablets (Promethazine Theoclate Tablets I.P.) 25 mg
Each uncoated tablet contains Promethazine Theoclate IP 25 mg.
Duration of Therapy: Post dose 24 hour housing in each study period.
Manufactured By: Abbott Health Care Pvt Ltd, India.
Marketed in India by: Abbott Health Care Pvt Ltd., India. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of this study is to evaluate bioequivalence after single oral administration of
test product versus single oral administration of reference product under fasting conditions in
healthy adult human male subjects. |
Pre-dose- 11 hours
Post-dose- 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
Pre-dose- 11 hours
Post-dose- 24 hours
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/06/2018 |
| Date of Study Completion (India) |
21/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of the study is to evaluate bioequivalence after single oral administration of test product versus single oral administration of reference product under fasting condition in healthy adult human male subjects. Study completed. |