Trial · NCT01151345

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.

NCT01151345, Phase 1, Completed, Pfizer; results first posted 2011-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT01151345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01151345

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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.
NCT number: NCT01151345
Status: Completed
Phases: Phase 1
Enrollment: 26 participants, actual
Lead sponsor: Pfizer
Conditions: Healthy
Interventions: TILACEM, ANGIOTROFIN
First posted: 2010-06-28
Last updated: 2011-09-12
Results first posted: 2011-08-22

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (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	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose	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-∞).
Primary	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
Primary	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
Primary	Plasma Decay Half-Life (t1/2)	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 is the time measured for the plasma concentration to decrease by one half.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (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	Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	ng*hr/mL	MEAN
PRIMARY	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose	Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	ng*hr/mL	MEAN
PRIMARY	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	PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	ng/mL	MEAN
PRIMARY	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	PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	hr	MEAN
PRIMARY	Plasma Decay Half-Life (t1/2)	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose	PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.	hr	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	Tilazem 60 mg	463.41	Standard Deviation 245.03	ng*hr/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	Angiotrofin 60 mg	498.87	Standard Deviation 226.07	ng*hr/mL
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	Tilazem 60 mg	612.95	Standard Deviation 298.23	ng*hr/mL
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	Angiotrofin 60 mg	648.68	Standard Deviation 283.73	ng*hr/mL
Maximum Observed Plasma Concentration (Cmax)	Tilazem 60 mg	68.67	Standard Deviation 50.36	ng/mL
Maximum Observed Plasma Concentration (Cmax)	Angiotrofin 60 mg	79.60	Standard Deviation 44.01	ng/mL
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Tilazem 60 mg	2.38	Standard Deviation 0.98	hr
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Angiotrofin 60 mg	2.44	Standard Deviation 1.04	hr
Plasma Decay Half-Life (t1/2)	Tilazem 60 mg	12.17	Standard Deviation 5.98	hr
Plasma Decay Half-Life (t1/2)	Angiotrofin 60 mg	11.71	Standard Deviation 5.55	hr

Source ClinicalTrials.gov

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention Period	STARTED	Tilazem 60 mg Then Angiotrofin 60 mg	13
First Intervention Period	STARTED	Angiotrofin 60 mg Then Tilazem 60 mg	13
First Intervention Period	Treated	Tilazem 60 mg Then Angiotrofin 60 mg	13
First Intervention Period	Treated	Angiotrofin 60 mg Then Tilazem 60 mg	12
First Intervention Period	COMPLETED	Tilazem 60 mg Then Angiotrofin 60 mg	13
First Intervention Period	COMPLETED	Angiotrofin 60 mg Then Tilazem 60 mg	12
First Intervention Period	NOT COMPLETED	Tilazem 60 mg Then Angiotrofin 60 mg	0
First Intervention Period	NOT COMPLETED	Angiotrofin 60 mg Then Tilazem 60 mg	1
Wash-out Period (7 Days)	STARTED	Tilazem 60 mg Then Angiotrofin 60 mg	13
Wash-out Period (7 Days)	STARTED	Angiotrofin 60 mg Then Tilazem 60 mg	12

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	General disorders	Tilazem 60 mg	5	25
other	Headache	General disorders	Angiotrofin 60 mg	6	25
other	Dizziness	General disorders	Tilazem 60 mg	4	25
other	Dizziness	General disorders	Angiotrofin 60 mg	4	25
other	Diarrhoea	General disorders	Tilazem 60 mg	1	25
other	Diarrhoea	General disorders	Angiotrofin 60 mg	2	25
other	Gastrointestinal pain	General disorders	Tilazem 60 mg	1	25
other	Gastrointestinal pain	General disorders	Angiotrofin 60 mg	0	25
other	Hypoaesthesia	General disorders	Tilazem 60 mg	1	25
other	Hypoaesthesia	General disorders	Angiotrofin 60 mg	0	25

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tilazem 60 mg
Total, all-cause mortality	Angiotrofin 60 mg
Total, other adverse events	Tilazem 60 mg	10	25
Total, other adverse events	Angiotrofin 60 mg	13	25
Total, serious adverse events	Tilazem 60 mg	0	25
Total, serious adverse events	Angiotrofin 60 mg	0	25

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Tilazem 60 mg vs Angiotrofin 60 mg: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01151345

GET https://conductscience.org/api/trials/v1/NCT01151345/registered

API reference For AI assistants