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.

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Healthy
Interventions
DRUG

TILACEM

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.

DRUG

ANGIOTROFIN

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.

Trial Locations (1)

14050

Pfizer Investigational Site, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY