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A randomized, double-blind, two-treatment, single-period, single-dose, parallel design, comparative bioavailability study between RTPR- 021 (test adalimumab) 40 mg/0.8 ml prefilled syringe from Reliance Life Sciences Pvt. Ltd., India and Humira® (reference adalimumab) 40 mg/0.8 ml prefilled syringe from Abbott biotechnology Germany in healthy, adult, human subjects following subcutaneous administration under fasting condition.

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Trial Profile

A randomized, double-blind, two-treatment, single-period, single-dose, parallel design, comparative bioavailability study between RTPR- 021 (test adalimumab) 40 mg/0.8 ml prefilled syringe from Reliance Life Sciences Pvt. Ltd., India and Humira® (reference adalimumab) 40 mg/0.8 ml prefilled syringe from Abbott biotechnology Germany in healthy, adult, human subjects following subcutaneous administration under fasting condition.

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Reliance Life Sciences

    • Most Recent Events

    • 30 Aug 2016 New trial record

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