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Phase 1Completed

15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions

Sponsor
Teva Pharmaceuticals USA (Industry)
Enrollment
32 enrolled
Conditions
Healthy
Interventions
Mirtazapine 15 mg (Orally Disintegrating) Tablets; REMERON SolTab® 15 mg Orally Disintegrating Tablets
Ages
adults, older adults
Registry
NCT00835575

Full record on ClinicalTrials.gov

From the registry

This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.

Primary outcomes

  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

History

  1. Last registry update

  2. Results first posted

  3. Registered

  4. Primary completion

  5. Started