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A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects including males between the ages of 18 and 55 years and/or females of
non childbearing potential between the ages of 18 and 55 years. (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
or clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- An informed consent document signed and dated by the subject.

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

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

- Evidence or history of clinically significant dermatologic, hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug screen.

- Use of tobacco- or nicotine- containing products (or a positive urine drug cotinine
test).

- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer
or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of study medication.

- 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If
QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTc or QRS values should be used to determine the
subject's eligibility.

- Pregnant or nursing females and females of childbearing potential including those with
tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who
are postmenopausal (defined as being amenorrheic for at least 2 years) must have
confirmatory FSH test results at Screening.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of study medication. Herbal
supplements and hormone replacement therapy must be discontinued at least 28 days
prior to the first dose of study medication. Depo Provera must be discontinued at
least 6 months prior to the first dose of study medication. As an exception,
acetaminophen/paracetamol may be used at doses of less than 1 g/day. Limited use of
non prescription medications that are not believed to affect subject safety or the
overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

NCT01313793
Pfizer
Completed
A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804

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A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804
A Phase 1 Open-Label Study Of Pf-00299804 In Healthy Volunteers To Demonstrate The Bioequivalence Of The Proposed Commercializable Formulation Administered As One 45-Mg Tablet Relative To Three 15-Mg Clinical Formulation Tablets
The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation. Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.
A bioequivalence (BE) study between two formulations of PF-00299804.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteers
  • Drug: Treatment A-B
    Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.
  • Drug: Treatment B-A
    Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.
  • Experimental: Sequence 1
    Subjects will receive clinical formulation (treatment A) followed by commercializable formulation (treatment B).
    Intervention: Drug: Treatment A-B
  • Experimental: Sequence 2
    Subjects will receive commercializable formulation (treatment B) followed by clinical formulation (treatment A).
    Intervention: Drug: Treatment B-A
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects including males between the ages of 18 and 55 years and/or females of non childbearing potential between the ages of 18 and 55 years. (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 or clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • Use of tobacco- or nicotine- containing products (or a positive urine drug cotinine test).
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication.
  • 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
  • Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication. Depo Provera must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01313793
A7471022
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

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.

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1-800-718-1021

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[email protected]



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