None listed
Conditions
Interventions
Intervention1: 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
Sponsors
Zenara Pharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-infTimepoint: 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
| Measure | Time frame |
|---|---|
| Tmax, t , Kel, Kel Lower, Kel Upper and AUCExtrapolated%Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Harisha C
Notrox Research Pvt Ltd
Outcome results
None listed