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.
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: TILACEM (Drug); ANGIOTROFIN (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] Maximum Observed Plasma Concentration (Cmax) Time to Reach Maximum Observed Plasma Concentration (Tmax) Plasma Decay Half-Life (t1/2)
Detailed description:
Bioequivalence of this particular drug
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Locations and Contacts
Pfizer Investigational Site, Mexico, DF 14050, Mexico
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: June 2010
Last updated: September 6, 2011
|