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

NCT01421043 | Completed Phase 1

• 1 other identifier: A6781003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

bioequivalence study; triazolam; liquid oral drops; tablet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• Time at maximum concentration (Tmax)

  0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose

Study Arms (2)

triazolam liquid oral drops

EXPERIMENTAL

Drug: triazolam liquid oral drops

triazolam tablets

ACTIVE COMPARATOR

Drug: triazolam tablets

Interventions

triazolam liquid oral drops DRUG

0.25 mg single dose oral drops

triazolam liquid oral drops

triazolam tablets DRUG

0.25 mg single oral dose

triazolam tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Triazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 24, 2016

Record last verified: 2011-10

Locations

BE (1)