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Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

- 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

NCT01017926
Pfizer
Withdrawn
Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption

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[email protected]

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Descriptive Information
Brief Title  ICMJE Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionThe bioequivalence trial of triazolam is due to change in manufacture site.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Triazolam
Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
Study Arms  ICMJE
  • Active Comparator: Triazolam Reference Arm
    There will be a clearance period of at least 3 days between the two phases of the study.
    Intervention: Drug: Triazolam
  • Experimental: Triazolam Trial Arm
    Intervention: Drug: Triazolam
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2009)
26
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion DateSeptember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017926
Other Study ID Numbers  ICMJE A6781002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Investigación Farmacológica y Biofarmacéutica
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now