- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421043
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
October 21, 2016 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium, B-1070
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: triazolam liquid oral drops
|
0.25 mg single dose oral drops
|
ACTIVE_COMPARATOR: triazolam tablets
|
0.25 mg single oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
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
|
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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)
Time Frame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
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
|
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
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
|
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
August 18, 2011
First Submitted That Met QC Criteria
August 18, 2011
First Posted (ESTIMATE)
August 22, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2016
Last Update Submitted That Met QC Criteria
October 21, 2016
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6781003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on triazolam liquid oral drops
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDCompletedAcute Upper Respiratory InfectionChina
-
Catharina Ziekenhuis EindhovenCompleted
-
West China HospitalActive, not recruitingCarcinoma, Non-Small-Cell Lung | Chemotherapy, AdjuvantChina
-
Anavex Life Sciences Corp.Anavex Australia Pty Ltd.; Anavex Germany GmbHCompletedRett SyndromeCanada, Australia, United Kingdom
-
China Academy of Chinese Medical SciencesXiyuan Hospital of China Academy of Chinese Medical SciencesUnknownRespiratory Infectious Diseases
-
GeneScience Pharmaceuticals Co., Ltd.Completed
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDCompletedAcute Upper Respiratory InfectionChina
-
Peking University Third HospitalBeijing Tiantan HospitalActive, not recruitingAcute Hemorrhagic StrokeChina
-
Ruijin HospitalRecruiting
-
Hong Kong Baptist UniversityJiangzhong Pharmaceutical Co., Ltd.Recruiting