Trial Outcomes & Findings for Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet (NCT NCT00917579)
NCT ID: NCT00917579
Last Updated: 2021-03-12
Results Overview
AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
COMPLETED
PHASE4
76 participants
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
2021-03-12
Participant Flow
Healthy volunteers were recruited from one research center between July 2008 and September 2008.
Participant milestones
| Measure |
Test Drug First, Then Reference Drug
New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
|
Reference Drug First, Then Test Drug
Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
|
|---|---|---|
|
Period 1: 1st Intervention
STARTED
|
39
|
37
|
|
Period 1: 1st Intervention
COMPLETED
|
39
|
37
|
|
Period 1: 1st Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout >= 2 Weeks
STARTED
|
39
|
37
|
|
Washout >= 2 Weeks
COMPLETED
|
37
|
37
|
|
Washout >= 2 Weeks
NOT COMPLETED
|
2
|
0
|
|
Period 2: 2nd Intervention
STARTED
|
37
|
37
|
|
Period 2: 2nd Intervention
COMPLETED
|
37
|
37
|
|
Period 2: 2nd Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Drug First, Then Reference Drug
New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
|
Reference Drug First, Then Test Drug
Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
|
|---|---|---|
|
Washout >= 2 Weeks
Adverse Event
|
1
|
0
|
|
Washout >= 2 Weeks
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Baseline characteristics by cohort
| Measure |
Total Number of Participants
n=76 Participants
All participants received atorvastatin 10 mg tablets (new and marketed).
|
|---|---|
|
Age, Customized
18-44 years
|
59 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
17 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dosePopulation: Pharmacokinetic (PK) parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, except 1 time point.
AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
|
Reference Drug
n=73 Participants
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
|
18.3206 ng•hr/mL
Standard Deviation 8.26454
|
19.2583 ng•hr/mL
Standard Deviation 8.79739
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dosePopulation: PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.
AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
|
Reference Drug
n=73 Participants
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
15.7382 ng•hr/mL
Standard Deviation 7.88920
|
16.5452 ng•hr/mL
Standard Deviation 8.71551
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dosePopulation: PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.
Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
|
Reference Drug
n=73 Participants
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
2.6594 ng/mL
Standard Deviation 1.44617
|
2.8086 ng/mL
Standard Deviation 1.23048
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dosePopulation: PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.
Tmax = time (hours) to maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
|
Reference Drug
n=73 Participants
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
1.000 hours
Interval 0.25 to 9.0
|
0.5000 hours
Interval 0.25 to 4.0
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dosePopulation: PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.
t1/2 = terminal elimination half-life in hours.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
|
Reference Drug
n=73 Participants
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Elimination Half-life (t1/2)
|
10.39 hours
Standard Deviation 4.0018
|
10.78 hours
Standard Deviation 3.9640
|
Adverse Events
Test Drug
Reference Drug
Serious adverse events
| Measure |
Test Drug
New (test) 10 mg atorvastatin tablet as a single oral dose.
|
Reference Drug
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
|
|---|---|---|
|
Renal and urinary disorders
Renal colic
|
1.3%
1/76
|
0.00%
0/74
|
Other adverse events
| Measure |
Test Drug
New (test) 10 mg atorvastatin tablet as a single oral dose.
|
Reference Drug
Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/76
|
5.4%
4/74
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/76
|
1.4%
1/74
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76
|
2.7%
2/74
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76
|
1.4%
1/74
|
|
Nervous system disorders
Dizziness
|
1.3%
1/76
|
1.4%
1/74
|
|
Nervous system disorders
Headache
|
1.3%
1/76
|
8.1%
6/74
|
|
Nervous system disorders
Syncope
|
0.00%
0/76
|
1.4%
1/74
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/76
|
2.7%
2/74
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/76
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/76
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/76
|
2.7%
2/74
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/76
|
1.4%
1/74
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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