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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

Page last updated: August 23, 2015

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