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CTRI Number  CTRI/2025/02/080998 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Open Label Single Dose Three Treatment Parallel Bioavailability Study Comparing Dydrogesterone Injection of Mankind Pharma Limited In Healthy Adult Female Subjects Under Fasting Conditions 
Scientific Title of Study   An Open Label Balanced Randomized Single Dose Three Treatment Three-Group Single Period Parallel Bioavailability Study Comparing Dydrogesterone Injection of Mankind Pharma Limited India In Healthy Adult Female Subjects Under Fasting Conditions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SLS-CL-0083-24-DYDR Version No 02 Dated 02 Jan 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore

Coimbatore
TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Source of Monetary or Material Support  
Mankind Pharma Limited 208 Okhla Industrial Estate Phase III New Delhi 110020 India 
 
Primary Sponsor  
Name  Mankind Pharma Limited 
Address  208 Okhla Industrial Estate Phase III New Delhi 110020 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Spinos Life Science and Research Private limited  Clinical Pharmacology unit Ground Floor No 29 A Krishna MaduravanamVellakinar pirivu Thudiyalur Coimbatore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep T  Spinos Life science and Research private limited  Clinical Pharmacology unit Clinical Department Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore 641029
Coimbatore
TAMIL NADU 		 08220586899

pradeep.t@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committee Registration No ECR/84/Indt/TN/2013/RR-19  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fasting Conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dydrogesterone 10 mg/mLIM injection  A Single dose of Dydrogesterone 10 mg/mL IM injection will be administered in study period Total Duration is 03 Days 
Intervention  Dydrogesterone 5 mg/mL IM injection  A Single dose of Dydrogesterone 5 mg/mL IM injection will be administered in study period Total Duration is 03 Days 
Intervention  Dydrogesterone 5 mg/mL SC injection  A Single dose of Dydrogesterone 5 mg/mL SC injection will be administered in study period Total Duration is 03 Days 
Comparator Agent  N/AP  N/AP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Normal healthy adult human female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 30.00 kg/m2
Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits are considered by the physician or principal or clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy, as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume Ovo lacto vegetarian diet
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination
Females of childbearing potential must have a negative serum pregnancy test performed within 21days prior to the initiation of the study and a negative urine pregnancy test prior to check in of study period
If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
non-childbearing potential defined as
greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active 
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Dydrogesterone or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within48.00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check-in of study period
Positive results for alcohol test prior to check-in of study period
Any blood donation excess blood loss within 90 days of check-in
Intake of any hormonal agent at any time within 14 days prior to the start of the study check-in
Use of hormone replacement therapy for a period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females are likely to become pregnant during the course of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Bioavailability of Dydrogesterone injection In Healthy Adult Female Subjects Under Fasting Conditions  28 Time Points
00 000 hrs 00 117 hrs 00 233 hrs 00 350 hrs 00 467 hrs 00 583 hrs 00 700 hrs 00 817 hrs 01 000 hrs 01 167 hrs 01 330 hrs 01 500 hrs 01 667 hrs 01 833 hrs 02 000 hrs 02 250 hrs 02 500 hrs 03 000 hrs 03 500 hrs 04 000 hrs 05 000 hrs 06 000 hrs 08 000 hrs 10 000 hrs 12 000 hrs 16 000 hrs 24 000 hrs and 36 000 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of Dydrogesterone injection in healthy adult Female subjects under fasting conditions  28 Time Points
00 000 hrs 00 117 hrs 00 233 hrs 00 350 hrs 00 467 hrs 00 583 hrs 00 700 hrs 00 817 hrs 01 000 hrs 01 167 hrs 01 330 hrs 01 500 hrs 01 667 hrs 01 833 hrs 02 000 hrs 02 250 hrs 02 500 hrs 03 000 hrs 03 500 hrs 04 000 hrs 05 000 hrs 06 000 hrs 08 000 hrs 10 000 hrs 12 000 hrs 16 000 hrs 24 000 hrs and 36 000 hrs 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/03/2025 
Date of Study Completion (India) 17/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
At least 18 number of healthy adult female subjects will be recruited to evaluate the bioavailability of Test product
As per the discretion of the Investigator a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 18 subjects in study period
In study period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 36.00 hours post-dose
In study period after an overnight fasting of at least 10.00 hours, in the morning a single dose of either Dydrogesterone 5 mg/mL IM injection or Dydrogesterone 10 mg/mL IM injection or Dydrogesterone 5 mg/mL SC injection, will be administered as per the randomization schedule
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes of before dosing and at 01.00 03.00 06.00 12.00 and 24.00 hours ± 60minutes post dose
Monitoring for adverse events will be done throughout the study period in clinical phase
 
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