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 Overview
=================
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

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TILACEM
* Drug: ANGIOTROFIN


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diltiazem<br> | Drug: TILACEM<br>* At 08:00 hours on day 1, CIF-BIOTEC personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.<br>Drug: ANGIOTROFIN<br>* At 08:00 hours on day 1, CIF-BIOTEC Pharmacy personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). | 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diltiazem, angiotrofin, bioequivalence