Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
NCT01151345
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- 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).
- Both genders
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs).
- 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 (eg, gastrectomy).
- A positive urine drug screen
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Descriptive Information | ||||
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Brief Title ICMJE | Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V. | |||
Official Title ICMJE | Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made By Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made By Amstrong Laboratorios De Mexico, S.A. DE C.V. Study In 26 Healthy Volunteers Of Both Genders Under Fasting Conditions | |||
Brief Summary | This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V. | |||
Detailed Description | Bioequivalence of this particular drug | |||
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 | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: diltiazem
Interventions:
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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 | Completed | |||
Actual Enrollment ICMJE | 26 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01151345 | |||
Other Study ID Numbers ICMJE | A7661002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |