| CTRI Number |
CTRI/2025/11/098004 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Single dose oral food effect bioavailability study of Usnoflast in healthy adult human subjects under fasting and fed conditions. |
|
Scientific Title of Study
|
Single dose oral food effect bioavailability study of Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule) in healthy adult human subjects under fasting and fed conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C1B05513, Ver 02,dated March 5,2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deven Parmar |
| Designation |
Chief Medical Officer & Head – Clinical R & D |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
dparmar@zydustherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maulik Doshi |
| Designation |
General Manager-Clinical R&D |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
maulik.doshi@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maulik Doshi |
| Designation |
General Manager-Clinical R&D |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
maulik.doshi@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhruv Patel |
Cliantha Research Limited |
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad
GUJARAT |
02717698500
dppatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee Sangini Hospital, Santorini Square, B/H Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Usnoflast (ZYIL1) |
Dose : 75 mg (50 mg + 25 mg capsule)capsule
Route : Oral
Duration : Single Dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Able to communicate effectively with study personnel.
2) Non-smokers, non-tobacco and non-alcoholic users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
3) Willing to provide written informed consent to participate in the study.
4) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication. |
|
| ExclusionCriteria |
| Details |
1) History of allergic responses to any drugs or any of usnoflast formulation ingredients.
2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
4) History or presence of bronchial asthma.
5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
6) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
7) History or evidence of drug dependence.
8) History of difficulty with donating blood or difficulty in accessibility of veins.
9) A positive hepatitis screen (includes subtypes B & C).
10) A positive test result for HIV antibody.
11) Volunteer who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
12) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
13) Intolerance to venipuncture
14) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study.
15) Institutionalized volunteer.
16) Use of any prescribed medications within 14 days prior to the first dose of study medication.
17) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
18) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
19) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
20) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
21) SGOT, SGPT and alkaline phosphatase values are 1.1 times higher than the upper limit of normal range during screening.
22) Serum bilirubin values are higher than the upper limit of normal range during screening.
23) Serum creatinine higher than upper limit during screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare and evaluate the oral bioavailability of Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule) in healthy, adult, human subjects under fasting and fed conditions. |
Baseline to end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of the subjects |
Baseline to end of study |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
30/11/2025 |
| 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
|
An open label, randomized, two-period, two-treatment,
[Treatment A (Investigational product administration under fasting condition)
vs Treatment B (Investigational product administration under fed condition)],
two-sequence, crossover, balanced, single dose oral food effect bioavailability
study. At least 11 hours prior
to dosing until at least 24 hours
post dose in each period.Considering the minimum washout period, expected study duration of
clinical part is 11 days from
the day of check-in of first period. Subject will remain seated upright for initial 04 hours
post-dose and only necessary movement will be allowed during this period. In each period, total 20 venous
blood samples (04 mL each) will
be collected at pre-dose (0.0 hour) and at 0.25, 0.5, 0.75, 1.0, 1.333, 1.667, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0,
10.0, 12.0, 16.0, 24.0, 36.0 and 48.0 hours post dose. |