Trial Outcomes & Findings for Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet (NCT NCT01004614)
NCT ID: NCT01004614
Last Updated: 2021-01-28
Results Overview
Area under the concentration-time curve from zero time until the last sampling time
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Results posted on
2021-01-28
Participant Flow
Participants were screened at one center in Japan.
This study consisted of 2 cohorts (I and II). The design of each cohort was an open-label, randomized, 2-periods, crossover, single-dose study in healthy adult male subjects. A washout period of at least 14 days was taken between each administration in Periods 1 and 2.
Participant milestones
| Measure |
3rd OD Tablet With Water, Then 2nd OD Tablet With Water
One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet With Water, Then 3rd OD Tablet With Water
One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
|
3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water
One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water
One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout
STARTED
|
12
|
12
|
12
|
12
|
|
Washout
COMPLETED
|
12
|
11
|
12
|
12
|
|
Washout
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
11
|
12
|
12
|
|
Second Intervention
COMPLETED
|
12
|
11
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
3rd OD Tablet With Water, Then 2nd OD Tablet With Water
One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet With Water, Then 3rd OD Tablet With Water
One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
|
3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water
One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water
One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
|---|---|---|---|---|
|
Washout
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Baseline characteristics by cohort
| Measure |
3rd OD Tablet With Water, Then 2nd OD Tablet With Water
n=12 Participants
One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet With Water, Then 3rd OD Tablet With Water
n=12 Participants
One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
|
3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water
n=12 Participants
One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water
n=12 Participants
One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
33.1 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Area under the concentration-time curve from zero time until the last sampling time
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
|
126.36 ng*h/mL
Standard Deviation 33.16
|
129.48 ng*h/mL
Standard Deviation 39.93
|
122.33 ng*h/mL
Standard Deviation 32.59
|
119.75 ng*h/mL
Standard Deviation 28.23
|
PRIMARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
2.70 ng/mL
Standard Deviation 0.513
|
2.74 ng/mL
Standard Deviation 0.650
|
2.48 ng/mL
Standard Deviation 0.470
|
2.45 ng/mL
Standard Deviation 0.409
|
SECONDARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule. AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration.
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
AUCinf
|
142.87 ng*h/mL
Standard Deviation 43.20
|
145.22 ng*h/mL
Standard Deviation 49.19
|
140.41 ng*h/mL
Standard Deviation 42.18
|
138.14 ng*h/mL
Standard Deviation 34.10
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
AUClast
|
124.14 ng*h/mL
Standard Deviation 33.96
|
127.36 ng*h/mL
Standard Deviation 40.91
|
121.05 ng*h/mL
Standard Deviation 33.76
|
118.27 ng*h/mL
Standard Deviation 29.43
|
SECONDARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Phase Rate Constant (Kel)
|
0.0174 L/h
Standard Deviation 0.0031
|
0.0179 L/h
Standard Deviation 0.0035
|
0.0162 L/h
Standard Deviation 0.0041
|
0.0156 L/h
Standard Deviation 0.0031
|
SECONDARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Terminal phase half-life calculated as ln(2) / kel
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Half-Life (T-half)
|
41.45 hour
Standard Deviation 9.76
|
40.27 hour
Standard Deviation 8.48
|
45.04 hour
Standard Deviation 10.16
|
46.20 hour
Standard Deviation 8.85
|
SECONDARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel\^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
61.29 hour
Standard Deviation 13.55
|
59.77 hour
Standard Deviation 11.99
|
66.18 hour
Standard Deviation 14.10
|
67.33 hour
Standard Deviation 11.90
|
SECONDARY outcome
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Outcome measures
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=23 Participants
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 Participants
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
8 hour
Interval 4.0 to 12.0
|
8 hour
Interval 4.0 to 12.0
|
8 hour
Interval 6.0 to 12.0
|
8 hour
Interval 6.0 to 12.0
|
Adverse Events
Cohort I: 3rd OD Tablet (Test) With Water
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort I: 2nd OD Tablet (Reference) With Water
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort II: 3rd OD Tablet (Test) Without Water
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort II: 2nd OD Tablet (Reference) Without Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort I: 3rd OD Tablet (Test) With Water
n=23 participants at risk
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
|
Cohort I: 2nd OD Tablet (Reference) With Water
n=24 participants at risk
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
|
Cohort II: 3rd OD Tablet (Test) Without Water
n=24 participants at risk
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
|
Cohort II: 2nd OD Tablet (Reference) Without Water
n=24 participants at risk
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.3%
1/23
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%
0/24
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%
0/24
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%
0/24
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23
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%
0/24
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.
|
4.2%
1/24
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%
0/24
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.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23
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%
0/24
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%
0/24
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.
|
4.2%
1/24
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.
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23
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.
|
4.2%
1/24
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%
0/24
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%
0/24
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.
|
|
Infections and infestations
Pharingitis
|
4.3%
1/23
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%
0/24
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%
0/24
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%
0/24
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.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23
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.
|
4.2%
1/24
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%
0/24
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%
0/24
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.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/23
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.
|
4.2%
1/24
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%
0/24
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%
0/24
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.3%
1/23
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%
0/24
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%
0/24
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%
0/24
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.3%
1/23
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.
|
4.2%
1/24
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%
0/24
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%
0/24
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.
|
|
Nervous system disorders
Headache
|
8.7%
2/23
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.
|
4.2%
1/24
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%
0/24
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.
|
4.2%
1/24
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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23
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%
0/24
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.
|
4.2%
1/24
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.
|
4.2%
1/24
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal disconfort
|
4.3%
1/23
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.
|
4.2%
1/24
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%
0/24
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%
0/24
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