None listed
Conditions
Interventions
Intervention1: Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt.Ltd, India: A Single oral dose of Elacestrant 345 mg Tablet will be administered ineach period Total Dura
Sponsors
BDR pharmaceuticals International Pvt.Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy Human Male and Post Menopausal Female subjects of age between 18-60 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 (according to the formula BMI = weight (kg) height (m)2 Female Subjects should have at least 12 month of amenorrhea Postmenopausal status confirmed by Screening Estradiol 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/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 non vegetarian diet Willing to comply with all requirements of this study protocol as well as instruction from the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination (for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check-in for each period Subjects should have protected sexual contact including dose interruptions by using a latex or synthetic condom every time they have sexual intercourse with a female of reproductive potential during study and for 02 weeks after receiving their last dose of Elacestrant even if they have undergone a successful vasectomy
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Elacestrant 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 within 48.00 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 e.g. 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 swallowing 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 this study period Positive results for alcohol test prior to check-in of each period Any blood donation excess blood loss within 90 days of check-in Ingestion 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 who are are likely to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence on Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed ConditionsTimepoint: 28 Time Points 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 33 hrs 01 67 hrs 0 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs and 72 00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy Human Male and Post Menopausal Female subjects under fed conditionsTimepoint: 28 Time Points 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 33 hrs 01 67 hrs 0 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs and 72 00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed