Aging Index & Prevalence Rate of Urinary Diseases in Korea

Benign Prostate Hyperplasia (BPH) & Nocturia

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DESMOPRESSIN OD!FS®

microgranule

‣ Oral Dissolving in a Few Seconds (A new concept of formulation which dissolves in a few seconds without water)

‣ Patented for new formulation platform technology

✓ KOREA PATENT PUBLICATION 1340733 (NOVEL MICROGRANULE FORMULATION)
✓ KOREA PATENT PUBLICATION 1340733 (MICROGRANULE FORMULATION INCLUDING COHESION UNIT CONSISTING OF DISCONTINUOUS PHASE AND CONTINUOUS PHASE)

DISSOLVED AT THE FASTEST
SPEED IN THE WORLD!

Incrementally
modified drug of
new formulation

  • Tablet → OD!FS® microgranule
    (orally dissolving microgranule)
  • Verified equality
    (primary clinical test performed with 60 attendants, Chungnam University Hospital)

Dosage


  • 0.1mg / sachet
  • 0.2mg / sachet

Administration


  • Oral administration at bed time
    → OD!FS® is the first product that can be administered without water
  • Peak in the blood while asleep
    → Nocturia is improved(maximized drug effect)

Features


  • Orally dissolving microgranule adminstered without water
  • The fastest orally dissolving formulation (within 3-5 seconds)
  • Diluting agent not affecting blood glucose level
  • Unnecessary to brush teeth after administration (no sugar is included)

Clinic trial (Phase I)

Title

A randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover study to evaluate the safety and pharmacokinetics of FOM-D31 and desmopressin tablet in healthy adult volunteers

Study phase

  • Phase 1

Condition

  • Healthy male, fasting, single dose, crossover

Enrollment

  • 60

Drug

  • Reference: Minirin tablet 0.2mg x 2ea
  • Test: Enurin OD!FS® microgranule 0.2mg x 2ea

Primary outcome measures

  • Bioequivalence based on Cmax and AUC

Study sponsor

  • FNG Research (affiliate of CorePharm bio)

Investigator

  • Clinical trial center of Chungnam National University Hospital

Pharmacokinetic parameters

PK Profiles of
Desmopressin acetate