A Study to evaluate the blood levels of Dapagliflozin 10mg and Metoprolol 50mg tablet as a Test compared to the Forxiga 10mg and Prolomet XL 50mg tablet as a Reference in a healthy subject under fasting conditions

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Dapagliflozin 10 mg and Metoprolol Succinate 50 mg Sustained‐Release Fixed‐Dose Combination Tablets (T). Manufactured by: Eris Lifesciences Ltd, Shivarth Ambit, Plot No 142/2, Ramdas Road Off SBR, Near Swati Bungalows, Bodakdev, Ahmedabad‐ 380054.: After an overnight fasting of at least 10.00 hours, a single dose Dapagliflozin 10 mg and Metoprolol Succinate 50 mg Sustained‐Release Fixed‐Dose Combination Tablets (T)Manufactured by Eris Lifesciences Ltd, India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. Subjects will receive the alternate â??treatmentâ?? in the subsequent periods, in such a way that each subject will have received all the â??treatmentsâ?? by the end of the study. Control Intervention1: Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Manufactured by: Astrazeneca pharmaceuticals, LP 4601 Highway 62 East, Mt. Vernon, Indiana 47620, USA. Prolomet® XL 50 (Metoprolol Succinate Extended Release 50mg Tablets IP) (R2) Manufactured by: Sun Pharma Laboratories Ltd., Vill: Kokjhar, Mirza palashbari road, P.O.: Palashbari, Dist: Kamrup, Assam‐781128.: After an overnight fasting of at least 10.00 hours, a single dose Forxiga® 10mg (Dapagliflozin 10mg Tablets) (R1) Manufactured by AstraZeneca Pharmaceuticals., USA and Prolomet® XL 50 (Metoprolol Succinate Extended Release 50mg Tablets IP) (R2) Manufactured by Sun Pharma Laboratories Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. Subjects will receive the alternate â??treatmentâ?? in the subsequent pe CONDITION: PRIMARY OUTCOME: Cmax, AUC(0‐t) and AUC(0‐inf)Timepoint: Total 24 blood samples in each period, a single pre‐dose (‐02.00 to 00.00) blood sample of 4.0 mL will be collected in each period. ; The post‐dose blood samples of 4.0 mL will be collected at 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and ; 48.00 hours post‐dose. 36.00 and 48.00 hours ambulatory visit. (window period as ± 60 minutes) SECONDARY OUTCOME: Tmax, Kel, t½ and AUC% Extrap obs(%)Timepoint: Total 24 blood samples in each period, a single pre‐dose (‐02.00 to 00.00) blood sample of 4.0 mL will be collected in each period. ; The post‐dose blood samples of 4.0 mL will be collected at 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and ; 48.00 hours post‐dose. 36.00 and 48.00 hours ambulatory visit. (window period as ± 60 minutes) INCLUSION CRITERIA: Volunteers who accept for participating in this study must: 1. Healthy, adult human, subjects aged between 18‐45 years (both inclusive) weighing at least 50 kg at the time of screening. 2. Having a Body Mass Inde X(BMI) between 18.50 to 30.00 kg/m2 (both inclusive) at the time of screening. 3. Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X‐ray chest (posterior‐anterior view) recordings. 4. Able to comply with the study procedures, in the opinion of the principal investigator. 5. Compliance with study specific restrictions and prohibitions. 6. Able to give voluntary written informed consent for participation in the trial. 7. Preferably non smoker and non alcoholic. In case of Female subjects: 8. Female subjects who are of child bearing potential and are surgically sterilized
Epistemonikos ID: d2765b8bf1d615543a70b15f8b3cf9952b89f277
First added on: Feb 20, 2024