None listed
Conditions
Interventions
Intervention1: Manforce (Sildenafil Citrate) 50mg Tablet of Mankind
Pharma Ltd: In each period, after an overnight fast of at least 10.00 hours, a single dose of investigational product, either one t
Sponsors
Mankind Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Wiling to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2) Willing to be available for the entire study period and to comply with protocol requirements. 3) Normal, healthy, adult, male subject of 18-45 years (both inclusive) of age. 4) Body mass index in the range of 18.5 30.0 kg/m2 (both inclusive) and body weight of not less than 50kg. 5) Healthy volunteers who are clinically non anemic shall be included as per the discretion of PI/CI/Physician. 6) Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period. 7) Laboratory evaluation within biological reference range/ biological acceptable range and performed within 28 days prior to Period I check-in for the study. The volunteers to be enrolled shall have laboratory parameters within predefined biological acceptable ranges. With a normal or clinically non-significant 12-lead ECG. 8) With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 9) Non-smokers and willing to abstain from smoking or chewing any tobacco containing product for at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points. 10) Male volunteer willing to use appropriate contraceptive measures to ensure that his female partner shall not get pregnant for at least 15 days post last dose/ entire study period. 11) Subject with negative urine test for drug of abuse. 12) Subject with negative alcohol breath test. 13) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
Exclusion criteria
Exclusion criteria: 1) Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs. 2) History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past along with chronic lymphocytic leukemia and small cell lymphocytic leukemia. Subjects with complete or partial syndrome of nasal polyps. 3) History or presence of renal dysfunction with GFR less than 60 mL/min. 4)History of loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION). 5)History or presence of active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 6)Use of antihypertensive drugs and pressor Agents (e.g. dopamine, dobutamine), use of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine), use of monoamine oxidase Inhibitors in the previous 14 days before first drug administration and till the completion of the study. 7)Subject with hepatic transaminase greater than 2 x ULN (upper limit of normal). 8)Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction 9)Any major illness or hospitalization within 90 days prior to check-in of first period 10)Subjects who have been on an unusual diet with low sodium intake or excessive protein intake or abnormal diet, for whatever reason e.g. because of Fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 11)Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected 12)Use of any prescribed medication (including herbal medicines and vitamin supplements) for at least 14 days prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected 13)Use of any OTC products for at least 07 days prior to first check-in and throughout the duration of the study until the post study safety sample is collected. 14)Use of any recreational drug or history of drug addiction 15)Use of CYP3A4 inhibitors or preparations containing St. John s wort 16)Participated in any clinical investigation requiring repeated blood sampling, blood donation, or otherwise recognizable blood loss in past 90 days prior to first check-in. 17)Participated in any clinical study within the past 90 days prior to check-in. 18)Consumption of alcohol or alcoholic products for at least 48.00 hrs. prior to check-in in each study period and throughout sampling time points. 19)Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) for at least 24.00 hours prior to check-in in each study period and throughout sampling time points. 20)Consumption of grapefruit or its juice for at-least 48.00 hours prior to check-in in each study period and throughout sampling time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of single dose of Manforce (Sildenafil Citrate) 50mg Tablet of Mankind Pharma Ltd. with VIAGRA (Sildenafil Citrate) 50mg Tablet of Viatris in healthy, adult, human male subjects under fasting condition and to prove the bioequivalence.Timepoint: The venous blood samples shall be withdrawn at pre-dose (00.00 hour) and 00.16, 00.25, 00.33, 00.50, 00.66, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 18.00 and 24.00 hours post-dose following drug administration in each period | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single dose of investigational medicinal products when administered orally in healthy, adult, human male subjects under fasting condition.Timepoint: Vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) and well-being shall be done before check-in, at pre-dose (within 02.00 hrs before dosing), and at 01.00, 03.00, 07.00 and 11.00 hrs after dosing (within 60 min of scheduled time of recording), at the time of check-out in each period. The well-being of subjects shall be ascertained at each vital sign measurement | — |
Countries
India
Contacts
Public ContactDr Lakshmikar B V
ICBio Clinical Research Private Limited
Outcome results
None listed