You are here

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 October 4, 2018

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption
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.
The bioequivalence trial of triazolam is due to change in manufacture site.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteers
Drug: Triazolam
Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01017926
A6781002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Investigación Farmacológica y Biofarmacéutica
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now