Healthy VolunteersPhase 1NCT01017926
Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption
A Phase 1 study testing Triazolam in people with Healthy Volunteers, run by Pfizer.
Trial summary
The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Triazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only healthy volunteers, between the ages of 18 and 40 years, will be included.
- Subjects' body mass index must be between 19-27.
- Volunteers must be in good health, as determined by the results of a complete clinical history prepared by doctors at the clinical research site and laboratory tests performed at certified clinical laboratories.
- Volunteers must agree to use at least two birth control methods (except hormonal contraceptives) from the first dose of the study drug and for up to 28 days after the last dose. (acceptable methods are surgically definitive sterilization, menopause, barrier methods such as condoms and diaphragm, and spermicidal gels/foams)
- The limits of variation permitted within normality at the screening visit will be: blood pressure (seated) 90 to 130 mm Hg systolic and 60 to 90 mm Hg diastolic, heart rate between 55 and 100 beats per minute and respiratory rate between 14 and 20 respirations per minute.
- The laboratory and cabinet tests required to include subjects in the studio will be: 1) Hematology: hemoglobin, hematocrit, total white blood cell count with differential, and platelet count, 2) 27-element blood chemistry, 3) Markers for hepatitis B and C. 4) Detection of HIV, 5) General urinalysis, 6) Drug abuse test in both study periods, 7) Qualitative pregnancy test in both study periods (if applicable) , 8) Electrocardiogram. (pre-screening/recruitment)
Who cannot join
- Subjects in whom any alteration is detected in their vital signs recorded at the screening of volunteers.
- Volunteers who fail to comply with the established criteria for inclusion.
- Volunteers with antecedents of cardiovascular, renal, hepatic, muscular, metabolic, and gastrointestinal disorders, including constipation; neurological, endocrine, and hematopoietic disorders; or any kind of anemia, asthma, mental illness, or other organic abnormalities, as well as those who have suffered a muscular traumatism within 21 days before the study.
- Volunteers who require any medication over the course of the study, aside from the drug being studied.
- Volunteers with antecedents of dyspepsia, gastritis, esophagitis, and duodenal or gastric ulcers.
- Volunteers who have been exposed to known hepatic enzyme inductors or inhibitors or have taken potentially toxic drugs within 30 days before the start of the study.
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- Volunteers who have received any medication within 14 days or 5 half lives (whichever is longer) before the start of the study.
- Volunteers who have been hospitalized for any problem within seven months before the start of the study.
- Subjects who have received investigational drugs within 60 days prior to the study.
- Subjects allergic to any antibiotic and/or non-steroidal antiinflammatory analgesics.
- Subjects who have consumed alcohol or xanthine containing beverages (coffee, tea, cocoa, chocolate, mate, colas) or have consumed charcoal broiled foods or grapefruit juice within one week before the start of the study and until the last sample is taken.
- Subjects who have donated or lost 450 mL or more of blood within 60 days before the start of the study.
- History of regular consumption of alcohol exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of liquor within 6 months before the screening visit.
- Excessive use of products containing tobacco or nicotine, equivalent to 5 cigarettes per day.
- Female volunteers with positive results on the pregnancy test or in lactation.
- Volunteers who require a special diet for any reason, for example vegetarians.
- Disability of any kind that prevents the volunteer from understanding the nature, purpose, and potential consequences of the study.
- Evidence of an uncooperative attitude during the study.
- Female volunteers in lactation.
- Female volunteers who receive oral contraceptives
About this study
Official title: An Open, Two Period, Two Treatment, Two Sequence, Crossed, Randomized, Single-Dose Study Of Two Oral Preparations Containing 0.25 Mg Of Triazolam (Halcion, Pharmacia & Upjohn S.A. De C.V. Vs. Product Made By Pfizer Pharmaceuticals LLC) In Healthy Volunteers Under Fasting Conditions
The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.
Read the detailed description
The bioequivalence trial of triazolam is due to change in manufacture site.
- Conditions
- Healthy Volunteers
- Being tested
- Triazolam
- Keywords
- Triazolam bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriazolamDrug
Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
TriazolamDrug
Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
| Study group | Role | What they receive |
|---|---|---|
| Triazolam Reference Arm | Active comparator | There will be a clearance period of at least 3 days between the two phases of the study. Receives: Drug: Triazolam |
| Triazolam Trial Arm | Experimental | Not described Receives: Drug: Triazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Triazolam in tablets
Measured: Day 1 and two after dosage is taken
Statistically compare the bioavailability of the pharmaceutical formulations of Triazolam studied, to establish or rule out the existence of bioequivalence
Measured: Six to eight weeks after completing the study, a final report will be prepared.
Secondary outcomes (1)
Investigate the safety of both preparations based on the record of adverse events on completing both study periods
Measured: Up to 3 days after the 2nd period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startAug 2010
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Investigación Farmacológica y Biofarmacéutica
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017926
- Sponsor's protocol ID
- A6781002
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2009
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Two Period, Two Treatment, Two Sequence, Crossed, Randomized, Single-Dose Study Of Two Oral Preparations Containing 0.25 Mg Of Triazolam (Halcion, Pharmacia & Upjohn S.A. De C.V. Vs. Product Made By Pfizer Pharmaceuticals LLC) In Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01017926
- Acronym / sponsor ID
- A6781002
- Conditions
- Healthy Volunteers
- Keywords
- Triazolam bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Investigación Farmacológica y Biofarmacéutica
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.
Detailed description
The bioequivalence trial of triazolam is due to change in manufacture site.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triazolam Reference Arm | Active comparator | Drug: TriazolamThere will be a clearance period of at least 3 days between the two phases of the study. |
| Triazolam Trial Arm | Experimental | Drug: Triazolam |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Only healthy volunteers, between the ages of 18 and 40 years, will be included.
- Subjects' body mass index must be between 19-27.
- Volunteers must be in good health, as determined by the results of a complete clinical history prepared by doctors at the clinical research site and laboratory tests performed at certified clinical laboratories.
- Volunteers must agree to use at least two birth control methods (except hormonal contraceptives) from the first dose of the study drug and for up to 28 days after the last dose. (acceptable methods are surgically definitive sterilization, menopause, barrier methods such as condoms and diaphragm, and spermicidal gels/foams)
- The limits of variation permitted within normality at the screening visit will be: blood pressure (seated) 90 to 130 mm Hg systolic and 60 to 90 mm Hg diastolic, heart rate between 55 and 100 beats per minute and respiratory rate between 14 and 20 respirations per minute.
Key exclusion criteria (20 listed)
- Subjects in whom any alteration is detected in their vital signs recorded at the screening of volunteers.
- Volunteers who fail to comply with the established criteria for inclusion.
- Volunteers with antecedents of cardiovascular, renal, hepatic, muscular, metabolic, and gastrointestinal disorders, including constipation; neurological, endocrine, and hematopoietic disorders; or any kind of anemia, asthma, mental illness, or other organic abnormalities, as well as those who have suffered a muscular traumatism within 21 days before the study.
- Volunteers who require any medication over the course of the study, aside from the drug being studied.
- Volunteers with antecedents of dyspepsia, gastritis, esophagitis, and duodenal or gastric ulcers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriazolamTablets, 0.25 mg, single-dose, 1 period of 3 three days. | Drug | Triazolam Reference Arm |
| TriazolamTablets, 0.25 mg, single-dose, 1 period of 3 three days. | Drug | Triazolam Trial Arm |
Primary outcome
Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Triazolam in tablets
Time frame: Day 1 and two after dosage is taken
Statistically compare the bioavailability of the pharmaceutical formulations of Triazolam studied, to establish or rule out the existence of bioequivalence
Time frame: Six to eight weeks after completing the study, a final report will be prepared.
1 secondary outcome
Investigate the safety of both preparations based on the record of adverse events on completing both study periods
Time frame: Up to 3 days after the 2nd period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triazolam in people with Healthy Volunteers, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Triazolam in tablets (time frame: Day 1 and two after dosage is taken). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.