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 drug being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in a bioequivalence study, which compares the absorption of TILACEM 60 mg tablets to a reference product.
TILACEM is developed by Pfizer, Inc. (NYSE: PFE). The drug is being studied in a Phase 1 clinical trial conducted in Mexico, with Pfizer, S.A. de C.V. as the manufacturer of the TILACEM 60 mg tablets used in the study.
TILACEM is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.
TILACEM has one completed clinical trial, NCT01151345, a Phase 1 bioequivalence study. The study enrolled 26 healthy volunteers in Mexico and compared TILACEM 60 mg tablets to a reference product. The trial was uncontrolled and not double-blinded.
Yes, TILACEM is also known as Tilazem 60. The clinical trial NCT01151345 refers to the drug as Tilazem 60, a 60 mg tablet formulation made by Pfizer, S.A. de C.V. The study compared this product to Angiotrofin 60 mg.