CTRI/2025/02/080998CompletedNot Applicable
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 Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mankind Pharma Limited
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- To evaluate the Bioavailability of Dydrogesterone injection In Healthy Adult Female Subjects Under Fasting Conditions
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To evaluate the Bioavailability of Dydrogesterone injection In Healthy Adult Female Subjects Under Fasting Conditions
Time Frame: 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 Outcomes
- To monitor the safety and tolerability of Dydrogesterone injection in healthy adult Female subjects under fasting conditions(28 Time Points)
Investigators
Dr Pradeep T
Spinos Lifescience and research private limited
Study Sites (1)
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