In-vivo Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug in Compared with The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) In Healthy Volunteers
An open label, randomized, balanced, two treatment, two sequence, two period, truncated, two way cross-over, single-dose, oral bioequivalence study of FDC of Linagliptin 05 mg, Dapagliflozin 10 mg and Metformin Hydrochloride 1000 mg extended release Tablets (T) Manufactured by Optimus Pharma Pvt. Ltd., India with Trajenta® 5 mg (Linagliptin 05 mg) Tablet (R1) Manufactured by West-Ward Columbus Inc., USA and Marketed by Boehringer Ingelheim India Pvt. Ltd., Maharashtra, India and Xigduo® XR (Dapagliflozin and Metformin HCl Extended Release Tablets 10 mg + 1000 mg) (R2) Manufactured by AstraZeneca Pharmaceuticals LP, USA and Imported & Marketed by AstraZeneca Pharma India Ltd., Bangalore, India in normal healthy, adult human subjects under fasting condition.
An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose, oral bioequivalence study of FDC of Dapagliflozin 10mg, Sitagliptin 100mg and Metformin Hydrochloride Sustained Release 1000 mg Tablets (T) Manufactured by Eris Lifesciences Ltd., India with Gluxit Trio 10/100/1000 (Dapagliflozin 10 mg, Sitagliptin 100 mg and Metformin Hydrochloride Extended Release 1000 mg Tablets) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, India in normal healthy, adult human subjects under fasting condition. - NIL
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