Full-service bioequivalence study AI

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This is a summary of information regarding the procurement “Full-service bioequivalence study” (ID: 2026/04/1).

Procurement object

  • Service: Full-service bioequivalence study (in cardiology, film-coated tablets).
  • Key technical requirements:
    • Study design: single-dose, randomized, two-treatment, two-period, two-sequence, two-phase crossover study in a fasted state.
    • Participants: healthy volunteers (~80% men, 20% women).
    • Sample size: Phase 1 ~40 participants, maximum (Nmax) ~60 participants.
    • Safety monitoring: cardiac monitoring (12-lead ECG) before and after dosing…
       
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938240-2-Olpha-Technical-specification-2026-04-1-16-04-2026.pdf

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