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Mirtazapine

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Mirtazapine · 2 trials · 1 indication

Phase 1 2
NCT0083419715 mg Mirtazapine Orally Disintegrating Tablets, Non-FastingHealthy
COMPLETED32 Analytics
NCT0083557515 mg Mirtazapine Orally Disintegrating Tablets, FastingHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
Healthy
NCT0083419732
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PHASE1COMPLETED
15 mg Mirtazapine Orally Disintegrating Tablets, Fasting
Healthy
NCT0083557532
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Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 120 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 120 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 120 hour period.

Bioequivalence based on AUC0-inf.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Mirtazapine 15 mg (Orally Disintegrating) TabletsDRUG1 x 15 mg, single-dose non-fasting
REMERON SolTab® 15 mg Orally Disintegrating TabletsDRUG1 x 15 mg, single-dose non-fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. * Screening Procedures: Each subject will complete the screening pr...

Countries:United States
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