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triazolam liquid

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 24, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

triazolam liquid · 1 trial · 1 indication

Phase 1 1
NCT01421043A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy SubjectsHealthy
COMPLETED34 Analytics
PHASE1COMPLETED
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
Healthy
NCT0142104334
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Study Endpoints

Primary Endpoints

Area Under the Curve (AUC) to last time point (t)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Maximum concentration of drug (Cmax)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose

Secondary Endpoints

Area Under the Curve (AUC) to time infinity (inf) (if data permit)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Area Under the Curve (AUC) percent extrapolated (%exp)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Half-life (if data permit)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
triazolam liquid oral dropsEXPERIMENTAL -
triazolam tabletsACTIVE_COMPARATOR -

Interventions

NameTypeDescription
triazolam liquid oral dropsDRUG0.25 mg single dose oral drops
triazolam tabletsDRUG0.25 mg single oral dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...

Countries:Belgium
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Frequently asked questions about triazolam liquid

What is triazolam liquid used for?

Triazolam liquid is an investigational oral drops formulation of triazolam being studied in healthy subjects. It is being evaluated for bioequivalence to a tablet formulation. The drug is in Phase 1 clinical development and is not yet approved for any indication.

Who makes triazolam liquid?

Triazolam liquid is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical trials to evaluate this oral drops formulation of triazolam.

What phase is triazolam liquid in?

Triazolam liquid is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug remains under clinical investigation.

What clinical trials is triazolam liquid in?

Triazolam liquid has one completed clinical trial, NCT01421043, titled "A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects." This Phase 1 study enrolled 34 participants in Belgium.

Is triazolam liquid the same as triazolam?

Triazolam liquid is an oral drops formulation of triazolam, the active pharmaceutical ingredient. The study compares this liquid formulation to a tablet formulation of triazolam to assess bioequivalence. Both contain the same drug substance but in different dosage forms.