Single Dose Oral Bioequivalence Study Comparing Everolimus Tablets For Oral Suspension 5 mg In Healthy Adult Human Trial participants Under Fed Conditions

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Everolimus Tablets For Oral Suspension 5 mg: A Single oral dose of Everolimus Tablets For Oral Suspension 5 mg will be administered in each period Total Duration is 19 Days Control Intervention1: Afinitor Disperz Everolimus Tablet For Oral Suspension 5 mg: A Single oral dose of Afinitor Disperz Everolimus Tablet For Oral Suspension 5 mg will be administered in each period Total Duration is 19 Days CONDITION: PRIMARY OUTCOME: To assess the Bioequivalence of Everolimus Tablets For Oral Suspension 5 mg Manufactured by Abon Pharmaceuticals LLC Chestnut Ridge NY 10977 with Afinitor Disperz Everolimus Tablet For Oral Suspension 5 mg Distributed By Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 In Healthy Adult Human trial participants under Fed ConditionsTimepoint: 21 Time points ; 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 60.00 Hrs 72.00 Hrs SECONDARY OUTCOME: To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human trial participants under fasting conditionsTimepoint: 21 Time points ; 00.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs 60.00 Hrs 72.00 Hrs INCLUSION CRITERIA: Normal healthy adult human trial participants of age between 18 to 45 years and Body Mass Inde XBMI ranges between 18.50 kg by m2 to 30 kg by m2 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 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 XRay and clinical laboratory assessments Willing to consume non vegetarian diet Willing to comply with all requirements of this study prot
Epistemonikos ID: 9ba9d2eb31f424aff7e114fa01afd101b6b54e77
First added on: Oct 08, 2026