No phaseStatus unknown

A clinical trial to study the effect of three drugs Sitagliptin Gliclazide and Metformin

An Open label, randomized, balanced, two treatment, two sequence, two period, two way cross over, single dose, oral bioequivalence study of Fixed Dose Combination of Sitagliptin Tablet 100 mg, Gliclazide Sustained Release Tablets 30 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg, Test product, Manufactured by Eris Lifesciences Limited, India with ALSITA M 100 contains Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg, Reference 1, manufactured by Alkem Health Sciences, India and DIAMICRON MR 30 mg contains Gliclazide modified Release Tablet 30 mg, Reference 2, Manufactured by Servier India Private Limited, India in normal healthy, adult human subjects under fed condition. - NIL

Sponsor
Eris Lifesciences Limited
Enrolment
24 planned
Interventions
Sitagliptin 100 mg, Gliclazide 30 mg and Metformin 500 mg Tablets
Registry
CTRI-2026-08-115896

Full record on the Clinical Trials Registry – IndiaSource: WHO ICTRP, processed 14 September 2026

Primary outcomes

  • Cmax, AUC0-t and AUC0-infTimepoint: Total 31 blood samples will be collected in each period. <br/ > The pre-dose and post-dose blood samples of 4.0 mL will be collected and placed in wet ice pack at 00.00, 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.

History

  1. Last registry update

  2. Started

  3. Registered