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Desmopressin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Desmopressin · 1 trial · 1 indication

Phase 1 1
NCT00835211Desmopressin Acetate 0.2 mg Tablets, FastingHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Desmopressin Acetate 0.2 mg Tablets, Fasting
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about Desmopressin

What is Desmopressin used for?

Desmopressin is a small molecule being developed by Teva Pharmaceutical Industries Limited. It is currently in Phase 1 clinical trials for use in healthy volunteers. The drug is being studied as an active-controlled treatment, with one completed trial involving 48 participants.

Who makes Desmopressin?

Desmopressin is being developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Desmopressin in?

Desmopressin is in Phase 1 clinical development. It has one completed trial, NCT00835211, which was a Phase 1 study in healthy volunteers. The drug is investigational and has not been approved for any indication.

What clinical trials is Desmopressin in?

Desmopressin has one clinical trial, NCT00835211, titled 'Desmopressin Acetate 0.2 mg Tablets, Fasting'. This Phase 1 study was completed and enrolled 48 healthy volunteers in Canada, with participants aged 18 years and older.

Is Desmopressin FDA approved?

Desmopressin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only trial for this drug, NCT00835211, has been completed, but approval status has not been established.