Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TILACEM · 1 trial · 1 indication
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
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-∞).
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| diltiazem | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TILACEM | DRUG | 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. |
| ANGIOTROFIN | DRUG | 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. |
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 ...
TILACEM is a small molecule medicine developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers in Mexico. The specific therapeutic indication for TILACEM is not publicly disclosed.
TILACEM is made by Pfizer, Inc., which trades under the ticker PFE. The Phase 1 bioequivalence study of TILACEM was conducted by Pfizer, S.A. de C.V., the company's Mexican subsidiary, in Mexico.
TILACEM is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a bioequivalence trial in healthy volunteers.
TILACEM has been evaluated in one completed clinical trial, NCT01151345, titled a bioequivalence study of diltiazem in 60 mg tablets as Tilazem 60 made by Pfizer, S.A. de C.V., versus Angiotrofin 60 mg. The trial enrolled 26 healthy adult volunteers in Mexico.
Yes, TILACEM contains diltiazem. The completed Phase 1 trial, NCT01151345, describes TILACEM as diltiazem in 60 mg tablets under the brand name Tilazem 60, made by Pfizer, S.A. de C.V.