None listed
Conditions
Interventions
Intervention1: Renegra 50 mg
Tablets (Sildenafil Citrate USP 50 mg Film Coated Tablets): After an overnight fasting of at least 10.00 hours, a single dose of Renegra 50 mg Tablets (Sildenafil Citrate
Sponsors
Rene Industries 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, clinical examination including vital signs, 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, will be excluded from the participation in this study: 1) Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug. 2) History of loss of vision in one eye because of non-arteritic anterior ischaemicoptic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase5 (PDE5) inhibitor exposure. 3) History of hypotension (blood pressure 90/50 mmHg), recent history of stroke or myocardial infarction (within the last 6 months), unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa. 4) Subjects with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). 5) Subjects who are on nitrates or nitric oxide donors (such as amyl nitrite) in any form, Alpha blockers, guanylate cyclase (GC) stimulators, such as riociguat. 6) 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. 7) Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator. 8) Habit of consuming high caffeine (more than 5 cups of coffee or tea/day). 9) Smokers and Alcoholics. 10) History or presence of asthma, urticaria or other allergic reactions. 11) History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. 12) 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. 13) The presence of clinically significant abnormal laboratory values during screening. 14) Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test. 15) A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study. 16) Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study. 17) Difficulty in swallowing capsule/tablet. 18) Positive HIV, VDRL/RPR, Hepatitis B and C tests. 19) 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. 20) History of any enzyme modifying drugs taken for 28 days prior to period I Check-in and nitrates for 30 days prior to dosing will be instructed to subjects not to take during the study. Prior to check-in of Period- I, complete the Inclusion and Exclusion Criteria Form (Attachment 01 to this protocol) for each volunteer. Only suitable volunteers should be allowed to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and assess the rate and extent of absorption of Renegra 50 mg Tablets (Sildenafil Citrate USP 50 mg Film Coated Tablets) (T) Manufactured by Rene Industries Ltd., Uganda with VIAGRA 50 mg (Sildenafil 50 mg Film Coated Tablets) (R) Marketing Authorisation Holder by Upjohn UK Limited, Ramsgate Road, Sandwich Kent, CT13 9NJ, United Kingdom.Timepoint: Total 27 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in wet ice pack at each period. The post-dose blood samples of 3.0 mL will be collected and placed in wet ice pack at 00.08, 00.17, 00.25, 00.33, 00.50, 00.67, 00.83, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects following administration of a single dose of test and reference product of Sildenafil Citrate 50 mg Film Coated Tablets.Timepoint: Total 27 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in wet ice pack at each period. The post-dose blood samples of 3.0 mL will be collected and placed in wet ice pack at 00.08, 00.17, 00.25, 00.33, 00.50, 00.67, 00.83, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00 hours post-dose. | — |
Countries
India
Contacts
Public ContactDr Divya A
M/s Notrox Research Pvt Ltd (NRPL)
Outcome results
None listed