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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421043
First received: August 18, 2011
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: triazolam liquid oral drops
Drug: triazolam tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Triazolam Liquid Oral Drops at a Dose of 0.25 Mg Versus Triazolam 0.25 Mg Tablet in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve (AUC) to last time point (t) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]
  • Maximum concentration of drug (Cmax) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve (AUC) to time infinity (inf) (if data permit) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) percent extrapolated (%exp) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]
  • Half-life (if data permit) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]
  • Time at maximum concentration (Tmax) [ Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: triazolam liquid oral drops Drug: triazolam liquid oral drops
0.25 mg single dose oral drops
Active Comparator: triazolam tablets Drug: triazolam tablets
0.25 mg single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421043

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01421043     History of Changes
Other Study ID Numbers: A6781003
Study First Received: August 18, 2011
Last Updated: October 14, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
bioequivalence study
triazolam
liquid oral drops
tablet

Additional relevant MeSH terms:
Triazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014