Trial Outcomes & Findings for Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet (NCT NCT00917644)
NCT ID: NCT00917644
Last Updated: 2021-02-21
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). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
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
2021-02-21
Participant Flow
Participant milestones
| Measure |
Test Drug First
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
|
Reference Drug First
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
|
|---|---|---|
|
Period 1: First Intervention
STARTED
|
39
|
37
|
|
Period 1: First Intervention
COMPLETED
|
39
|
37
|
|
Period 1: First Intervention
NOT COMPLETED
|
0
|
0
|
|
Period: Washout Period of > = 2 Weeks
STARTED
|
39
|
37
|
|
Period: Washout Period of > = 2 Weeks
COMPLETED
|
37
|
37
|
|
Period: Washout Period of > = 2 Weeks
NOT COMPLETED
|
2
|
0
|
|
Period 2: Second Intervention
STARTED
|
37
|
37
|
|
Period 2: Second Intervention
COMPLETED
|
36
|
37
|
|
Period 2: Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test Drug First
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
|
Reference Drug First
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
|
|---|---|---|
|
Period: Washout Period of > = 2 Weeks
Protocol Violation
|
1
|
0
|
|
Period: Washout Period of > = 2 Weeks
Withdrawal by Subject
|
1
|
0
|
|
Period 2: Second Intervention
family emergency
|
1
|
0
|
Baseline Characteristics
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Baseline characteristics by cohort
| Measure |
Total Study Population
n=76 Participants
New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
|
|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 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: PK parameter analysis population defined as all subjects randomized and treated who had \> = 1 of the parameters of primary interest in \> = 1 treatment period.
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). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 Participants
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
|
168.1355 ng*hr/mL
Standard Deviation 100.77765
|
176.1731 ng*hr/mL
Standard Deviation 120.18642
|
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
AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 Participants
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
162.5073 ng*hr/mL
Standard Deviation 100.56590
|
170.4735 ng*hr/mL
Standard Deviation 119.70585
|
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
Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 Participants
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
43.1782 ng/mL
Standard Deviation 31.70609
|
43.0534 ng/mL
Standard Deviation 36.47166
|
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
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 Participants
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
1.0 hours
Interval 0.5 to 4.0
|
1.0 hours
Interval 0.5 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
t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Outcome measures
| Measure |
Test Drug
n=76 Participants
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 Participants
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Elimination Half-life (t1/2)
|
9.330 hours
Standard Deviation 3.1792
|
9.444 hours
Standard Deviation 4.0157
|
Adverse Events
Test Drug
Reference Drug
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Drug
n=76 participants at risk
New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
|
Reference Drug
n=74 participants at risk
Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/76
|
0.00%
0/74
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/76
|
0.00%
0/74
|
|
Gastrointestinal disorders
Toothache
|
1.3%
1/76
|
0.00%
0/74
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/76
|
0.00%
0/74
|
|
General disorders
Fatigue
|
0.00%
0/76
|
1.4%
1/74
|
|
Infections and infestations
Dermatophytosis
|
1.3%
1/76
|
0.00%
0/74
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/76
|
0.00%
0/74
|
|
Nervous system disorders
Headache
|
7.9%
6/76
|
4.1%
3/74
|
|
Nervous system disorders
Paraesthesia
|
1.3%
1/76
|
0.00%
0/74
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/76
|
0.00%
0/74
|
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