A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: triazolam tablets; Drug: triazolam liquid oral drops

• Registration Number: NCT01421043
• Lead Sponsor: Pfizer

Brief Summary

This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-22
• Study Start: 2011-09
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
triazolam tablets	triazolam tablets	-
triazolam liquid oral drops	triazolam liquid oral drops	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Half-life (if data permit)	0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Time at maximum concentration (Tmax)	0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium