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An Assessor-Blind, Randomized, Three-Treatment, Three- Period, Single-Dose, Crossover, Bioequivalence Study of INTG8 of Intas Pharmaceuticals Limited, India to Forteo (Lilly USA, LLC) and Forsteo (Eli Lilly Nederland B.V., The Netherlands) in Healthy Men and Postmenopausal Women after Subcutaneous Administration

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Trial Profile

An Assessor-Blind, Randomized, Three-Treatment, Three- Period, Single-Dose, Crossover, Bioequivalence Study of INTG8 of Intas Pharmaceuticals Limited, India to Forteo (Lilly USA, LLC) and Forsteo (Eli Lilly Nederland B.V., The Netherlands) in Healthy Men and Postmenopausal Women after Subcutaneous Administration

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jan 2023

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At a glance

  • Drugs Teriparatide (Primary)
  • Indications Fracture; Osteoporosis
  • Focus Pharmacokinetics
  • Sponsors Intas Pharmaceuticals

Most Recent Events

  • 01 Jan 2023 Primary endpoint has been met (AUC from time zero extrapolated to infinity (AUC0-), as per Results published in the Osteoporosis International
  • 01 Jan 2023 Primary endpoint has been met (area under the curve (AUC) from time zero to t (AUC0-t), as per Results published in the Osteoporosis International
  • 01 Jan 2023 Primary endpoint has been met (Maximum serum concentration (Cmax), as per Results published in the Osteoporosis International

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