None listed
Conditions
Sponsors
BDR pharmaceuticals International Pvt Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg by m2 to 30 kg by 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 or 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 may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments Willing to consume non vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by 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 initiation of the study and a negative urine pregnancy test prior to check in of each period If 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
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Deucravacitinib 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 Trial participants with chronic or recurrent infection and known to latent tuberculosis and with a history of a serious or an opportunistic infection and with underlying conditions that may predispose them to infection History of alcohol addiction or abuse Trial participants who have received live attenuated vaccines immediately prior to the study or scheduled to receive during the study 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 and throughout 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence Study Comparing Deucravacitinib 6 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India With SOTYKTU Deucravacitinib 6 mg Tablet Distributed by Bristol Myers Squibb Company Princeton New Jersey 08543 USA in healthy adult human trial participants under fasting conditionsTimepoint: 24 Time points 00.00 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 05.00 Hrs 05.50 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human trial participants under fasting conditionsTimepoint: 24 Time points 00.00 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 05.00 Hrs 05.50 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed