A double-blind, randomized, single dose, two-period, two-way crossover bioequivalence study between two Recombinant DNA human soluble Insulin Formulations - Wockhardt's rDNA human regular Insulin Injection (Wosulin R) 100 IU/mL with Actrapid HM Penfill (Regular, Human Insulin injection [rDNA origin] IP) 100 IU/mL, 3.0 mL of Imported by: Novo Nordisk India Private Limited and Manufactured by: Novo Nordisk Producao Farmaceutica do Brasil Ltda. Brazil 39404004, INDIA in healthy, adult, male subjects under fasting condition. - PK PD Trial

Trial Profile

A double-blind, randomized, single dose, two-period, two-way crossover bioequivalence study between two Recombinant DNA human soluble Insulin Formulations - Wockhardt's rDNA human regular Insulin Injection (Wosulin R) 100 IU/mL with Actrapid HM Penfill (Regular, Human Insulin injection [rDNA origin] IP) 100 IU/mL, 3.0 mL of Imported by: Novo Nordisk India Private Limited and Manufactured by: Novo Nordisk Producao Farmaceutica do Brasil Ltda. Brazil 39404004, INDIA in healthy, adult, male subjects under fasting condition. - PK PD Trial

Discontinued
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Insulin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Wockhardt
  • Most Recent Events

    • 01 Sep 2016 New trial record
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