Diabetes Mellitus, Non-Insulin-DependentNCT00550329
Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets
An observational study of Diabetes Mellitus, Non-Insulin-Dependent and Hyperglycemia, run by Pfizer at 1 site in Singapore.
Trial summary
The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets manufactured at the facility in Barceloneta, Puerto Rico. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent, Hyperglycemia
- What is being tested?
- Glipizide GITS
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2007to Nov 2007
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
- 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.
- Subjects who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- 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).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
- 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.
- History or evidence of habitual tobacco- or nicotine-containing products within 3 months of screening or a positive urine or serum cotinine test.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
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- 12-lead ECG demonstrating QTc >450 msec at Screening.
- 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.
- 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.
- 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.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets Manufactured At Brooklyn, New York Versus At Barceloneta, Puerto Rico In Healthy Subjects
The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets manufactured at the facility in Barceloneta, Puerto Rico.
- Being tested
- Glipizide GITS
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glipizide GITSDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550329
- Sponsor's protocol ID
- A1251009
- Status last verified
- Oct 2008
- First submitted
- 26 Oct 2007
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets Manufactured At Brooklyn, New York Versus At Barceloneta, Puerto Rico In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00550329
- Acronym / sponsor ID
- A1251009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 29 Oct 2007 (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 objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets manufactured at the facility in Barceloneta, Puerto Rico.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
- 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.
- Subjects who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Key exclusion criteria (13 listed)
- 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).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
- 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.
- History or evidence of habitual tobacco- or nicotine-containing products within 3 months of screening or a positive urine or serum cotinine test.
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 |
|---|---|---|
| Glipizide GITS | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Non-Insulin-Dependent and Hyperglycemia, run by Pfizer at 1 site in Singapore.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Oct 2008.