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.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TILACEM; Drug: ANGIOTROFIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151345

A7661002

Details and patient eligibility

About

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.

Full description

Bioequivalence of this particular drug

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

diltiazem

Experimental group

Treatment:

Drug: ANGIOTROFIN

Drug: TILACEM