| CTRI Number |
CTRI/2024/07/070466 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To study the safety and bioavailability of Fexofenadine oral suspension |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Cross Over Partial Replicate Reference scaled Oral Bioavailability Study Comparing Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL Manufactured by Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India with Telfast (Fexofenadine Hydrochloride) Tablets 180 mg Marketing Authorisation Holder Opella Healthcare UK Limited Trading as Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT United Kingdom In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0053-23-FEXO Version No 02 Date 22 Apr 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground floor
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground floor
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground floor
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Mahashiv Limited
UK Unit 1
Kataria Point
1 Riches Road llford
England - IG1 1JH |
|
|
Primary Sponsor
|
| Name |
Mahashiv Limited |
| Address |
Mahashiv Limited
UK Unit 1
Kataria Point
1 Riches Road llford
England - IG1 1JH |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Lifescience and Research Private Limited |
Clinical Pharmacology Unit
Ground Floor 29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post
Coimbatore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Lifescience and Research Private Limited |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam
Vellakinar Pirivu G N Mills Post
Coimbatore
TAMIL NADU |
8220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fexofenadine Hydrochloride Oral Suspension |
180 mg/5 mL
Oral Dose
Three (each period one time) |
| Comparator Agent |
Telfast Tablets |
180 mg
Oral Dose
Three (each period one time) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments
Willing to consume Ovo lacto-vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
Generally healthy as documented by gynaecological examination and breast examination
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Fexofenadine Hydrochloride or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Any disease or condition which might compromise the haemopoeitic gastrointestinal hepatic renal cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in swallowing accessibility of veins
Positive results for urine screen of drugs of abuse alcohol test prior to check in
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioavailability on Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL with Telfast tablets 180 mg |
22 blood samples
00.00 hours, 00.25 hours, 00.50 hours, 00.75 hours, 01.00 hours, 01.25 hours, 01.50 hours, 01.75 hours, 02.00 hours, 02.33 hours, 02.67 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 06.00 hours, 08.00 hours, 10.00 hours, 12.00 hours, 16.00 hours and 24.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the palatability (Test Product) safety & tolerability of single dose administered in healthy adult human subjects under fasting conditions |
22 blood samples
00.00 hours, 00.25 hours, 00.50 hours, 00.75 hours, 01.00 hours, 01.25 hours, 01.50 hours, 01.75 hours, 02.00 hours, 02.33 hours, 02.67 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 06.00 hours, 08.00 hours, 10.00 hours, 12.00 hours, 16.00 hours & 24.00 hours |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Enough volunteers shall be
recruited in order to evaluate and start the study with at least 48 subjects,
as this Bioavailability study
will be conducted on healthy, adult, human subjects.
As per the discretion
of Investigator, additionally a sufficient number of stand-by subjects will be
included to ensure successful dosing of 48 subjects in
period I.Demographic data, medical and medication
history, physical examination, 12 lead ECG, haematology, biochemistry,
serology, urine routine analysis and
additionally for females serum pregnancy test, hormone assay (FSH) will be done
within 21 days and chest X-ray within 06 months prior to check-in. In each period subjects
will be housed in the clinical facility for at least 11.00 hours pre-dose to 24.00
hours post-dose and the washout period of at least 05 days from the successive
dosing day.
|