| CTRI Number |
CTRI/2025/10/096497 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
A Study of ZY-19489 300mgX3 capsules vs 900 mg single tablet Administered Via Oral Route in Healthy Adult Human Subjects |
|
Scientific Title of Study
|
A Randomized, Open Label, Single dose, Parallel Bioavailability Study of ZY-19489 300mgX3 capsules vs 900 mg single tablet Administered Via Oral Route in Healthy Adult Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZY19489 1003,Ver 01,17 June 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 Hardik Patel |
| Designation |
Senior Manager |
| 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 |
Hardik.Patel@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardik Patel |
| Designation |
Senior Manager |
| 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 |
Hardik.Patel@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Research Centre,
Sarkhej- Bavla N.H. No.8A, Moraiya,
Ahmedabad-382213
Phone:02717-665555, Ext. 580
|
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Research Centre,
Survey no 417,.419 and 420 ,Sarkhej- Bavla N.H. No.8A, Moraiya,Sanand
Ahmedabad-382213
Phone: 02717-665555, Ext. 580
|
| 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 |
| DrHardik Patel |
Zydus Research Centre |
"Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. N. 8A, Moraiya-382213
Ahmadabad
GUJARAT |
8511601660
hardik.patel@zyduslife.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe- Riddhi Medical Nursing Home Institutional Ethics Committee Riddhi Medical Nursing Home, A-101 Jalaram Plaza, Jawahar chowk, Maninagar, Ahmedabad - 380008, 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 |
NA |
NA |
| Intervention |
ZY-19489 |
Dose:300 mg x 3 capsule
Route:Oral Duration:-Single dose Frequency: Once |
| Intervention |
ZY-19489 |
Dose:900 mg tablet
Route:Oral
Duration:-Single dose
Frequency: Once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and/or non-pregnant, non-lactating female subjects aged between 18 and 50 years (Both inclusive).
2.Male subjects and/or female subjects of childbearing potential must agree to use effective contraception till study completion.
3.Body weight greater than 50 kg and BMI within the range greater than equal to 18.5 - less than equal to 29.9 kg/m2 (Both inclusive).
4.Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
5.Ability to communicate effectively with study personnel.
6.Participants who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator.
|
|
| ExclusionCriteria |
| Details |
1.History of alcohol consumption or tobacco use or drug abuse within the past 1 year of enrollment or subject’s currently taking alcohol and/or tobacco products.
2.Difficulty with donating blood or Inability to be venipuncture or tolerate venous puncture
3.Systolic blood pressure more than 140 mmHg or less than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg.
4.Pulse rate less than 55/minute or more than 100/minute.
5.Any clinically significant laboratory or ECG findings during screening as per discretion of investigator.
6.Surgery within last 3 months or planned major surgery within next 3 months from the date of screening.
7.Any major illness during last 3 months as per Investigator discretion.
8.Volunteers who have participated in any drug research study within past 3 months.
9.Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
10.History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reactions.
11.Subjects not willing to use contraceptives till completion of the study.
12.Subjects who are found positive urine alcohol test or urine test for drug of abuse at the time of check in.
13.Female subjects with history of pregnancy or lactation in the past 3 months
14.Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures.
15.Difficulty in swallowing of tablet or capsule.
16.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug.
17.Participants who have recent illness (eg, fever) within 14 days of enrollment.
18.Consumption of beverages or food containing xanthene bases including red bull, chocolate, coffee, etc. from 48 hours prior to enrollment.
19.Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. Diarrhoea).
20.Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participants unsuitable for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bioavailability of ZY-19489 tablet with ZY-19489 capsule administered to healthy participants. |
Day 0 to Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of ZY-19489. |
Day 0 to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is
randomized, open label, single dose, parallel, bioavailability study of ZY-19489
900 mg tablet with ZY-19489 300 mg * 3 capsules of Zydus Lifesciences Ltd.
Administered orally to healthy human adult subjects aged 18-50 years,
inclusive.
After
confirmation of the eligibility, subjects will be admitted in the clinical unit
on Day (-1). Study drug will be administered on Day 0 after overnight fast. Eligible
subjects will receive a single dose of ZY-19489 900 mg [ZY-19489 900 mg tablet
or ZY-19489 900 mg (300 mg* 3) capsules of Zydus Lifesciences Ltd.] as per the
randomization schedule.
After dosing on day 0, each subject will remain
confined within the clinical unit for 48 hours post dose for safety assessments
and blood sampling for PK analysis. Subject will report to the clinical
facility on Day 3, Day 5, Day 7, Day 14 and Day 28 as ambulatory visits. |