None listed
Conditions
Interventions
Intervention1: Elacestrant 345 mg Tablet: A Single oral dose of Elacestrant 345 mg Tablet will be administered in each period Total Duration is 23 Days
Control Intervention1: Orserdu Elacestrant 345 m
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 Trial Participants of age between 18 to 45 and 45 to 60 years respectively and Body Mass Index BMI ranges between 18.50 kg/m2 to 30.00 kg/m2 Postmenopausal status confirmed by Screening serum Estradiol and Follicle stimulating hormone FSH for Female trial participants only Trial participant within post menopausal limits or clinically non significant laboratory evaluation results for Serum Estradiol and FSH for Female trial participants only Trial Participants who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Trial Participants 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 instructions from the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination for female Trial Participants period I only Male trial prticipants willing to use adequate contraception during sexual intercourse with female partners of child bearing potential during the study and for a period of 02 weeks after receiving last dose of Elacestrant
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Elacestrant or its inactive ingredients Trial Participants 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 of each period and until completion of the 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 until completion of the study Trial Participants who have taken any prescription medications within 14 days prior to study check in of each period and until completion of the study and any over the counter medicinal products herbal medications within 07 days prior to study check in of each period and until completion of the study Trial Participants who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and until completion of the study Trial participant 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 each 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 Trial Participants demonstrating a positive pregnancy screen Female Trial Participants who are currently lactating Females are likely to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence of Elacestrant 345 mg tablet manufactured by BDR Pharmaceuticals International Pvt Ltd India with Orserdu Elacestrant 345 mg Film Coated Tablet Market Authorization Holder and manufactured by Stemline Therapeutics BV Basisweg 10 1043 AP Amsterdam The Netherlands in healthy human male and post menopausal female trial participants under fed conditionsTimepoint: 28 Time points 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.25 Hrs 02.50 Hrs 02.75 Hrs 03.00 Hrs 03.25 Hrs 03.50 Hrs 03.75 Hrs 04.00 Hrs 04.25 Hrs 04.50 Hrs 04.75 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 24.00 Hrs 48.00 Hrs 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 trial participants under fed conditionsTimepoint: 28 Time points 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.25 Hrs 02.50 Hrs 02.75 Hrs 03.00 Hrs 03.25 Hrs 03.50 Hrs 03.75 Hrs 04.00 Hrs 04.25 Hrs 04.50 Hrs 04.75 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed