| CTRI Number |
CTRI/2026/01/101997 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A drug-drug interaction study in healthy adult human subjects under fasting conditions. |
|
Scientific Title of Study
|
A drug-drug interaction study of Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule)] and Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL, (equivalent to 10 mg/mL of caffeine base) (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Each mL contains 2 mg of Midazolam base) (Dose = 2 mg) and Bupropion 75mg Tablet] in healthy adult human subjects under fasting conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C1B05514, Ver 01 , dated 12 March 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deven V Parmar MD FCP |
| Designation |
Chief Medical Officer & Head – Clinical R & D |
| Affiliation |
Zydus Lifescience Ltd |
| Address |
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
dparmar@zydustherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maulik Doshi MD DM |
| Designation |
General Manager |
| Affiliation |
Zydus Lifescience Ltd |
| Address |
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Maulik.Doshi@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maulik Doshi MD DM |
| Designation |
General Manager |
| Affiliation |
Zydus Lifescience Ltd |
| Address |
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmadabad
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
|
| Name |
Address |
| Ms Zydus Lifesciences Limited |
Survey No. 417, 419 & 420 Sarkhej-Bavla National Highway No. 8A,
Village- Moraiya Sanand (India)- 382210. |
|
|
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
Tel#+91-2717-698500"
Ahmadabad
GUJARAT |
9978336240
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 |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caffeine Citrate + Midazolam Hydrochloride + Bupropion |
Dose : 20 mg/mL + 2mg/mL + 75 mg
Form : Oral Solution + Syrup + tablet
Route : Oral
Duration : Single Dose |
| Comparator Agent |
NA |
NA |
| Intervention |
Usnoflast |
Dose : 75 mg (50 mg +25 mg)
Form : Capsule
Route : Oral
Duration : 14 days |
|
|
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)Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test performed within 28 days of the first dose of study medication. They must be using an acceptable form of contraception.
3)18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point.
4)Able to communicate effectively with study personnel.
5) 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)
6) Willing to provide written informed consent to participate in the study.
7) 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 Caffeine, Bupropion & Midazolam or other related drugs, or any of its and usnoflast formulation ingredients.
2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording and Chest X-ray, 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 respiratory conditions (i.e., moderate to severe asthma, chronic obstructive pulmonary disease [COPD], etc.).
5) Use of any hormone replacement therapy within 3 months prior to Period 1 dosing.
6) Use of any depot injection or implant of any drug within 3 months prior to Period 1 dosing.
7)Use of CYP enzyme inhibitors or inducers within 30 days prior to Period 1 dosing.
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) Volunteer who have received a known investigational drug within seven elimination half-life of the administered drug prior to Period 1 dosing.
13)History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
14)Intolerance to venipuncture.
15)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.
16)Institutionalized volunteer
17)Use of any prescribed medications within 30 days prior to Period 1 dosing.
18)Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to Period 1 dosing.
19)Use of grapefruit and grapefruit containing products within 7 days prior to Period 1 dosing.
20)Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and except protocol defined drug B1 (Caffeine Citrate Oral Solution) administration, recreational drugs within 72 hours prior to Period 1 dosing.
21)Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to Period 1 dosing.
22) SGOT, SGPT and alkaline phosphatase values are 1.1 times higher than the upper limit of normal range during screening.
23) Serum bilirubin values are higher than the upper limit of normal range during screening.
24) Serum creatinine higher than upper limit during screening
25) History or symptoms of narrow angle glaucoma.
26) History of head trauma.
27) History or presence of seizure, epilepsy, central nervous system (CNS) tumor, bulimia, anorexia nervosa.
28) History or presence of severe hepatic cirrhosis.
29) Volunteer who are undergoing abrupt discontinuation of sedatives (including benzodiazepines). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the drug-drug interaction of Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule)] and Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL, (equivalent to 10 mg/mL of caffeine base) (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup (Each mL contains 2 mg of Midazolam base) 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in healthy adult human subjects under fasting conditions. |
Day 1 to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of the subjects |
Day 1 to Day 14 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="1"
Months="0"
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
|
An open label, non-randomized, three-period, two-treatment, single-sequence, a drug-drug interaction study. The study will be conducted in three-period. Period I: Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 01.
Period II: Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule] will be administered twice a day (morning & evening) on Day 01 and once a day in the morning on Day 02 and Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 02.
Period III: Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule] will be administered twice daily (morning & evening) for 13 days and once a day in the morning on Day 14 and Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 14. |