CTRI/2026/02/103179 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On:
29/01/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to compare two sildenafil 50 mg tablets in healthy adult men under fasting conditions
Scientific Title of Study
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.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICBio/004/0126; Ver 00; 12 Jan 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Lakshmikar B V
Designation
Director
Affiliation
ICBio Clinical Research Private Limited
Address
ICBio Clinical Research Pvt. Ltd.
2, Survey, 8/1/2 ICBio tower II,
Devi Circle, Yelahanka Main Road, Vidyaranyapura,
Bangalore-560 097, Karnataka, INDIA.
Bangalore KARNATAKA 560097 India
Phone
918069423000
Fax
Email
pi.mail@icbiocro.com
Details of Contact Person Scientific Query
Name
Dr Lakshmikar B V
Designation
Director
Affiliation
ICBio Clinical Research Private Limited
Address
ICBio Clinical Research Pvt. Ltd.
2, Survey, 8/1/2 ICBio tower II,
Devi Circle, Yelahanka Main Road, Vidyaranyapura,
Bangalore-560 097, Karnataka, INDIA.
KARNATAKA 560097 India
Phone
918069423000
Fax
Email
pi.mail@icbiocro.com
Details of Contact Person Public Query
Name
Dr Lakshmikar B V
Designation
Director
Affiliation
ICBio Clinical Research Private Limited
Address
ICBio Clinical Research Pvt. Ltd.
2, Survey, 8/1/2 ICBio tower II,
Devi Circle, Yelahanka Main Road, Vidyaranyapura,
Bangalore-560 097, Karnataka, INDIA.
KARNATAKA 560097 India
Phone
918069423000
Fax
Email
pi.mail@icbiocro.com
Source of Monetary or Material Support
ICBio Clinical Research Private Limited
# 2, Survey # 8/1/2 ICBio tower II, Devi Circle,
Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore-560097 India.
Primary Sponsor
Name
Mankind Pharma Ltd
Address
208, Okhla Industrial Estate,
Phase III, New Delhi – 110020
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
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 Lakshmikar B V
ICBio Clinical Research Private Limited
2, Survey, 8/1/2 ICBio tower II, Devi Circle,
Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura,
Bangalore-560097 India Bangalore KARNATAKA
918069423000
pi.mail@icbiocro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
ACE Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
NA
Intervention / Comparator Agent
Type
Name
Details
Intervention
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 tablet of, Test product (T) or Reference product (R) allocated as per the randomization schedule shall be administered orally in sitting posture with 240±2mL of drinking water in each period at ambient temperature
Comparator Agent
VIAGRA® (Sildenafil Citrate) 50mg Tablet of
Viatris.
In each period, after an overnight fast of at least 10.00 hours, a single dose of investigational product, either one tablet of, Test product (T) or Reference product (R) allocated as per the randomization schedule shall be administered orally in sitting posture with 240±2mL of drinking water in each period at ambient temperature
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
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.
ExclusionCriteria
Details
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 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
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 Outcome
Outcome
TimePoints
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.
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
Target Sample Size
Total Sample Size="36" Sample Size from India="36" 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)
23/02/2026
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="0" Months="0" Days="10"
Recruitment Status of Trial (Global)
Not Applicable
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
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