| CTRI Number |
CTRI/2025/12/098743 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bioavailability study of Saroglitazar
Magnesium tablets 1 mg in healthy adult human participants under fasting
and fed conditions. |
|
Scientific Title of Study
|
Single dose oral food effect bioavailability study of Saroglitazar
Magnesium tablets 1 mg in healthy adult human participants under fasting
and fed conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C1B06313,Ver 01,03 October 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 Taufik Momin |
| 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 |
Taufik.Momin@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taufik Momin |
| 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 |
Taufik.Momin@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| M/s. Cliantha Research Limited, Dream Arcadia, Opp. Mayfair Atrium, Vadsar-Kalali Ring Road, Vadodara, Gujarat- 390012) |
|
|
Primary Sponsor
|
| Name |
Zydus Therapeutics Inc. |
| Address |
73C Route 31N,
Pennington
New Jersey 08534, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Butesh Sakaria MBBS |
Cliantha Research Limited |
Dream Arcadia,
Opp. Mayfair Atrium,
Vadsar-Kalali Ring Road
Vadodara – 390012
Vadodara
GUJARAT |
02652324376
bsakaria@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee Anand Multispeciality Hospital, Vadodara B Tower Sundarvan Complex Beside IOCL Petrol Pump Near Gorwa ITI Vadodara – 390016 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 |
Saroglitazar Magnesium tablets |
Fasting Condition
Dose :- 1 mg
Duration :- Single
Dose Route :- Oral Frequency : Onc |
| Intervention |
Saroglitazar Magnesium tablets |
Fed Condition
Dose :- 1 mg
Duration :- Single Dose
Route :- Oral
Frequency : Once
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Male and/or non-pregnant, non-lactating female
2)BMI:18.5 to 30.0 kg/m2, both inclusive
3)Able to communicate effectively with study personnel.
4)Non-smokers, non-tobacco and non-alcoholic users (i.e. having no past history of alcoholism, smoking and tobacco consuming for at least one year prior to study)
5)Willing to provide written informed consent to participate in the study.
6)All participants 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 Saroglitazar or other related drugs, or any of its 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 participants)].
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)Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication.
8)History or evidence of drug dependence.
9)History of difficulty with donating blood or difficulty in accessibility of veins.
10)A positive hepatitis screen (includes subtypes B & C).
11)A positive test result for HIV antibody.
12)Participant who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
13)Participant who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or greater than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
14) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
15) Intolerance to venipuncture
16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the
principal investigator or sub-investigator, could contraindicate the participant’s
participation in this study.
17) Institutionalized participant.
18) Use of any prescribed medications within 14 days prior to the first dose of study medication.
19) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
20) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
21) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
22) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
23) Participant having sitting systolic blood pressure less than 100 mmHg or greater than 140 mmHg or sitting diastolic blood pressure less than 60 mmHg or greater than 90 mmHg and pulse rate less than 60 or greater than 100 per minute during screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the oral bioavailability of Saroglitazar Magnesium tablets 1 mg in healthy, adult, human participants under fasting and fed conditions. |
Day 0 to Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of the participants. |
Day 0 to Day 2 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
23/12/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
A Single dose oral food effect bioavailability study of Saroglitazar Magnesium tablets 1 mg in healthy adult human participants under fasting and fed conditions.
Participants will receive one of the treatments mentioned below in each study period as per the randomization schedule.
Treatment A - Investigational product administration under fasting condition. Treatment B - Investigational product administration under fed condition.
Treatment A - For fasting condition:
Test product Saroglitazar Magnesium tablets 1 mg will be administered orally to the participants as per the randomization schedule in a sitting posture with about 240 mL of water at ambient temperature in each period
Treatment B - For fed condition:
Test product Saroglitazar Magnesium tablets 1 mg will be administered orally 30 minutes after starting the standardized high-calorie and high-fat breakfast to the participants as per the randomization schedule in a sitting posture with about 240 mL of water at ambient temperature in each period under the supervision of trained study personnel. |