Trial Outcomes & Findings for 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 NCT01151345)
NCT ID: NCT01151345
Last Updated: 2011-09-12
Results Overview
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
Results posted on
2011-09-12
Participant Flow
Participant milestones
| Measure |
Tilazem 60 mg Then Angiotrofin 60 mg
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
|
Angiotrofin 60 mg Then Tilazem 60 mg
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
|
|---|---|---|
|
First Intervention Period
STARTED
|
13
|
13
|
|
First Intervention Period
Treated
|
13
|
12
|
|
First Intervention Period
COMPLETED
|
13
|
12
|
|
First Intervention Period
NOT COMPLETED
|
0
|
1
|
|
Wash-out Period (7 Days)
STARTED
|
13
|
12
|
|
Wash-out Period (7 Days)
COMPLETED
|
13
|
12
|
|
Wash-out Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
13
|
12
|
|
Second Intervention Period
COMPLETED
|
13
|
12
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tilazem 60 mg Then Angiotrofin 60 mg
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
|
Angiotrofin 60 mg Then Tilazem 60 mg
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
|
|---|---|---|
|
First Intervention Period
Protocol Violation
|
0
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=26 Participants
Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
|
|---|---|
|
Age Continuous
|
33.0 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dosePopulation: 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.
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Outcome measures
| Measure |
Tilazem 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
|
463.41 ng*hr/mL
Standard Deviation 245.03
|
498.87 ng*hr/mL
Standard Deviation 226.07
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dosePopulation: 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.
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-∞).
Outcome measures
| Measure |
Tilazem 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
|
612.95 ng*hr/mL
Standard Deviation 298.23
|
648.68 ng*hr/mL
Standard Deviation 283.73
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dosePopulation: 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.
Outcome measures
| Measure |
Tilazem 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
68.67 ng/mL
Standard Deviation 50.36
|
79.60 ng/mL
Standard Deviation 44.01
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dosePopulation: 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.
Outcome measures
| Measure |
Tilazem 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
2.38 hr
Standard Deviation 0.98
|
2.44 hr
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dosePopulation: 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Tilazem 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 Participants
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
12.17 hr
Standard Deviation 5.98
|
11.71 hr
Standard Deviation 5.55
|
Adverse Events
Tilazem 60 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Angiotrofin 60 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tilazem 60 mg
n=25 participants at risk
Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
|
Angiotrofin 60 mg
n=25 participants at risk
Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
|
|---|---|---|
|
General disorders
Headache
|
20.0%
5/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
24.0%
6/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Dizziness
|
16.0%
4/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.0%
4/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Diarrhoea
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.0%
2/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gastrointestinal pain
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hypoaesthesia
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Muscular weakness
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Tremor
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Blepharitis
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Nausea
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Somnolence
|
0.00%
0/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
1/25
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER