single Dose single Period parallel bioequivalence study comparing ferric carboxymaltose injection 100 mg Iron per 2 ml in healthy adult human trial participants under fasting conditions

INTERVENTION: Intervention1: Ferric Carboxymaltose Injection 100 mg Iron/2 mL: A Single oral dose of Ferric Carboxymaltose Injection 100 mg Iron/2 mL will be administered in each period Total Duration is 09 Days Control Intervention1: INJECTAFER Ferric Carboxymaltose injection 100 mg Iron/2 mL: A Single oral dose of INJECTAFER Ferric Carboxymaltose injection 100 mg Iron/2 mL will be administered in each period Total Duration is 09 Days CONDITION: PRIMARY OUTCOME: To assess the Bioequivalence of Ferric Carboxymaltose Injection 100 mg Iron/2 ml Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd with INJECTAFER Ferric Carboxymaltose Injection 100 mg Iron/2 ml Marketing Authorisation holder American Regent Inc Shirley NY 11967 USA in healthy adult human trial participants under fasting conditionsTimepoint: 31 Time points ; ‐24.00 Hrs ‐12.00 Hrs ‐02.00 Hrs 00.00 Hrs 00.03 Hrs 00.08 Hrs 00.16 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.16 Hrs 01.33 Hrs 01.50 Hrs 01.67 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 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 96.00 Hrs 120.00 Hrs 144.00 Hrs SECONDARY OUTCOME: To evaluate the safety and tolerability of test product comparing with the reference product in healthy adult human trial participants under fasting conditionsTimepoint: 31 Time points ; ‐24.00 Hrs ‐12.00 Hrs ‐02.00 Hrs 00.00 Hrs 00.03 Hrs 00.08 Hrs 00.16 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.16 Hrs 01.33 Hrs 01.50 Hrs 01.67 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 04.00 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 96.00 Hrs 120.00 Hrs 144.00 Hrs INCLUSION CRITERIA: Normal Adult human trial participants of age between 18 to 45 years and Body Mass Inde XBMI ranges between 18.50 kg/m2 to 30.00 kg/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 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 Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as