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Clinical trial

A Prospective, Randomized, Double Blind, Active Controlled Study to Compare PK & Safety of Biosimilar Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd. With Humira 40 mg/ 0.4ml of Abbvie Ltd. in Healthy, Adult, Human Subject by Single Subcutaneous Injection Followed by Efficacy & Safety Study in Patients With Rheumatoid Arthritis

NCT05172817 is registered in ClinicalTrials.gov with Institute for Developing Science and Health Initiatives, Bangladesh as lead sponsor.

NCT NCT05172817
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Randomized, Double Blind, Active Controlled Study to Compare PK & Safety of Biosimilar Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd. With Humira 40 mg/ 0.4ml of Abbvie Ltd. in Healthy, Adult, Human Subject by Single Subcutaneous Injection Followed by Efficacy & Safety Study in Patients With Rheumatoid Arthritis
Lead sponsor
Institute for Developing Science and Health Initiatives, Bangladesh
Phase
Phase 2/3
Overall status
Unknown status
Start date
June 2, 2021
Completion date
October 30, 2022
Enrollment
200 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

efficacy, pharmacokinetics, rheumatoid arthritis, safety