CTRI/2026/01/102198 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
NA
Study Design
Randomized, Crossover Trial
Public Title of Study
To evaluate the absorption of Riociguat 2.5 mg tablets (T) compared to ADEMPAS® (riociguat) 2.5 mg tablets (R) in normal healthy, adult male subjects under fasting condition.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two period, two-way crossover, single-dose, oral bioequivalence study of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 & 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India with ADEMPAS® (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states in normal healthy, adult male subjects under fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
S-25-901, Version 01, dated 21-Jul-2025, Amd-01
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Harisha C
Designation
Principal Investigator
Affiliation
Notrox Research Pvt Ltd
Address
No 19/3, 2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road, (Behind Metro Cash and carry), Bangalore KARNATAKA 560062 India
Phone
08026861077
Fax
-
Email
harisha-c@notroxresearch.com
Details of Contact Person Scientific Query
Name
Dr Harisha C
Designation
Principal Investigator
Affiliation
Notrox Research Pvt Ltd
Address
No 19/3, 2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road, (Behind Metro Cash and carry),
KARNATAKA 560062 India
Phone
08026861077
Fax
-
Email
harisha-c@notroxresearch.com
Details of Contact Person Public Query
Name
Dr Harisha C
Designation
Principal Investigator
Affiliation
Notrox Research Pvt Ltd
Address
No 19/3, 2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road, (Behind Metro Cash and carry),
KARNATAKA 560062 India
Phone
08026861077
Fax
-
Email
harisha-c@notroxresearch.com
Source of Monetary or Material Support
Zenara Pharma Pvt. Ltd.
Plot No: 83/B, 84 & 87-96
Phase III, IDA Cherlapally,
Hyderabad-500051, India.
Primary Sponsor
Name
Zenara Pharma Pvt. Ltd.
Address
Plot No: 83/B, 84 & 87-96
Phase III, IDA Cherlapally,
Hyderabad-500051, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Harisha C MBBS
Notrox Research Pvt Ltd
No 19/3, 3rd Floor, Bikasipura Main Rd, JC
Industrial Layout Bangalore KARNATAKA
080-26861077 - harisha-c@notroxresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Shettys Oncology and Multispeciality Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
ADEMPAS (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states
After an overnight fasting of at least 10.00 hours, a single dose of ADEMPAS® (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states will be administered along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Intervention
Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 and 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India
After an overnight fasting of at least 10.00 hours, a single dose of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 and 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India will be administered along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
Volunteers who accepts for participating in this study must be:
1) Healthy, adult male, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2) Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
3) Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
4) Able to comply with the study procedures, in the opinion of the Principal Investigator.
5) Compliance with study specific restrictions and prohibitions.
6) Able to give voluntary written informed consent for participation in the trial.
ExclusionCriteria
Details
If any subject is having any of the following conditions, then exclude him from participation in this study:
1) Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2) Subjects with a history of previous use of medicines like ACE and ARB inhibitor.
3) History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
4) Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening
5) Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening.
6) Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening.
7) Respiratory rate below 12 or above 20 breaths per minute at the time of screening.
8) Body temperature below 96.2o F or above 99.8o F at the time of screening.
9) SpO2 less than 94% at the time of screening.
10) Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study. In any such case subject selection will be at the discretion of the Principal Investigator.
11) Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
12) Smokers and Alcoholics.
13) History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
14) An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
15) The presence of clinically significant abnormal laboratory values during screening.
16) Use of any recreational drugs or history of drug addiction or testing positive in pre-study Urine drug screening and Alcohol breath analyzer test.
17) A history of difficulty with donating blood or having donated blood in the preceding 90 days for males prior to the start of the study.
18) Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males preceding the start of the study.
19) Difficulty in swallowing tablets.
20) Positive HIV, VDRL/RPR, Hepatitis B and C tests.
21) Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC0-t and AUC0-inf
Total 22 blood samples in each period, a single pre-dose (-01.00 to 00.00) blood sample of 4.0 mL will be collected and placed in wet ice pack eachperiod. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers. The post-dose blood samples of 4.0 mL will be collected and placed in wet ice pack at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hours post-dose.
Secondary Outcome
Outcome
TimePoints
Tmax, t½, Kel, Kel Lower, Kel Upper and AUCExtrapolated%
otal 22 blood samples in each period, a single pre-dose (-01.00 to 00.00) blood sample of 4.0 mL will be collected and placed in wet ice pack eachperiod. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers. The post-dose blood samples of 4.0 mL will be collected and placed in wet ice pack at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hours post-dose.
Target Sample Size
Total Sample Size="46" Sample Size from India="46" 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)
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 Yet Recruiting
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
After an overnight fasting of at least 10.00 hours, a single dose of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 & 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India or ADEMPAS® (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states will be administered along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.