An Open-Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-dose, Crossover, Oral Bioequivalence Study 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.

Mankind Pharma Ltd1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2026年2月23日最近更新: 2026年1月29日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 36
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an open-label, randomized, two-treatment, two-period, two-sequence, single-dose crossover oral bioequivalence study conducted in healthy adult male subjects under fasting conditions to compare Manforce (Sildenafil Citrate) 50 mg Tablet (Test, Mankind Pharma Ltd.) with VIAGRA (Sildenafil Citrate) 50 mg Tablet (Reference, Viatris). In each study period, after an overnight fast of at least 10 hours, subjects receive a single oral dose of either the test or reference product with 240 ± 2 mL of water under supervision, with mouth checks to ensure complete ingestion. Pharmacokinetic evaluation includes primary parameters Cmax, AUC0-t, and AUC0–inf, and secondary parameters AUCExtrap, Tmax, half life, and Kel, where applicable. Bioequivalence is concluded if the 90% confidence intervals for the ratio of geometric least squares means of log-transformed Cmax, AUC0-t, and AUC0-inf fall within the acceptance range of 80.00–125.00%, while safety and tolerability are assessed throughout the study

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Male

入选标准

•Wiling to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
•Willing to be available for the entire study period and to comply with protocol requirements.
•Normal, healthy, adult, male subject of 18-45 years (both inclusive) of age.
•Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive) and body weight of not less than 50kg.
•Healthy volunteers who are clinically non anemic shall be included as per the discretion of PI/CI/Physician.
•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.
•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.
•With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
•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.
•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.
•Subject with negative alcohol breath test.
•Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.

排除标准

•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 points. 21)History of allergy or hypersensitivity or intolerance to Sildenafil or its formulation excipients which, in the opinion of the PI/CI/Physician, would compromise the safety of the subject or the study. 22)Difficulty in swallowing the investigational product. 23)History of difficulty in accessibility of veins in arms 24)Evidence of an uncooperative attitude.

研究者

发起方

Mankind Pharma Ltd

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Dr Lakshmikar B V

ICBio Clinical Research Private Limited

研究点 (1)

Loading locations...

相似试验

已完成

1 期

Bioequivalence Study of WP205 in Healthy Participants

NCT07281872Wanbangde Pharmaceutical Group Co., LTD20

已完成

不适用

Bioequivalence study of Propiomazine Tablets 25 mg in healthy, adult, human Subjects under fasting conditions.

CTRI/2024/04/066196Centaur Pharmaceuticals Pvt. Ltd40

尚未招募

不适用

Bioavailability study of Amaryl (glimepiride) Tablet 1 mg in healthy, adult, human subjects under fed condition

CTRI/2024/11/076291Sanofi Healthcare India Private Limited16

尚未招募

不适用

Bioavailability study of Amaryl (glimepiride) Tablet 1 mg in healthy, adult, human subjects under fasting condition

CTRI/2024/11/076292Sanofi Healthcare India Private Limited14

已完成

2/3 期

A study to evaluate the blood levels of Brivaracetam SR Tablets 200 mg to measure the pharmacokinetic profiles, safety and tolerability of the Test product (of Optimus Pharma Pvt. Ltd.) when compared to the reference product (BRITZILAM SR Tablets 200 mg) in a healthy subject in a fasting condition.

CTRI/2024/02/062873Optimus Pharma Pvt Ltd24