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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Triazolam

Criteria

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.