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Desmopressin

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Sep 11, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00835211Desmopressin Acetate 0.2 mg Tablets, FastingPHASE1 COMPLETED 48 — — Jul 1, 2003Aug 1, 2003Sep 11, 20091 Canada
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Study Endpoints
Primary Endpoints
Cmax - Maximum Observed Concentration
Blood samples collected over 12 hour period

Bioequivalence based on Cmax

AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 12 hour period

Bioequivalence based on AUCinf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 12 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Desmopressin Acetate 0.2 mg TabletsDRUG4 x 0.2 mg, single-dose fasting
DDAVP® 0.2 mg TabletsDRUG4 x 0.2 mg, single-dose fasting
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age; * Weighing at least 60 kg for males and 52 kg for females; * Subjects who had a body mass index (BMI) less tha...

Countries:Canada
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