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Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Insulin-Dependent Diabetes Mellitus, Hyperglycemia
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

1. 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). Subjects below the age of 21
years must have consent from either a parent or guardian in countries having this
requirement.

2. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >45 kg
(99 lbs).

3. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the trial.

4. Subjects who are willing and able to comply with the 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

1. 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).

2. Any condition possibly affecting drug absorption (e.g., gastrectomy).

3. A positive urine drug screen.

4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
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.

5. History or evidence of habitual tobacco- or nicotine-containing products within 3
months of screening or a positive urine or serum cotinine test.

6. Treatment with an investigational drug within 30 days preceding the first dose of
study medication.

7. 12-lead ECG demonstrating QTc >450 msec at Screening.

8. Sitting blood pressure ?140 mm Hg systolic or ?90 mm Hg diastolic on a single
measurement [confirmed by a single repeat, if necessary] following at least 5 minutes
of rest at Screening.

9. Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of non-hormonal contraception as outlined in this
protocol from at least 14 days prior to the first dose of study medication until
completion of follow-up procedures.

10. Use of prescription or nonprescription drugs, vitamins and dietary supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of study
medication. Herbal supplements and hormonal methods of contraception (including oral
and transdermal contraceptives, injectable progesterone, progestin subdermal implants,
progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement
therapy must be discontinued 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 may be used at doses of ?1g/day. Other
exceptions may be granted by a qualified member of Pfizer study management.

11. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

12. Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.

13. 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.

NCT00550329
Pfizer
Completed
Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets

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*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2007
Not Provided

Inclusion Criteria:

  1. 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). Subjects below the age of 21 years must have consent from either a parent or guardian in countries having this requirement.
  2. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
  3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
  4. Subjects who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  1. 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).
  2. Any condition possibly affecting drug absorption (e.g., gastrectomy).
  3. A positive urine drug screen.
  4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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.
  5. History or evidence of habitual tobacco- or nicotine-containing products within 3 months of screening or a positive urine or serum cotinine test.
  6. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
  7. 12-lead ECG demonstrating QTc >450 msec at Screening.
  8. Sitting blood pressure ?140 mm Hg systolic or ?90 mm Hg diastolic on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest at Screening.
  9. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of follow-up procedures.
  10. Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 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 may be used at doses of ?1g/day. Other exceptions may be granted by a qualified member of Pfizer study management.
  11. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  12. Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  13. 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
Singapore
 
 
NCT00550329
A1251009
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

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]



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