Trial Outcomes & Findings for Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food. (NCT NCT01254396)
NCT ID: NCT01254396
Last Updated: 2021-02-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Results posted on
2021-02-01
Participant Flow
Participant milestones
| Measure |
Sildenafil Fasted First, Then Sildenafil Fed
Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
|
Sildenafil Fed First, Then Sildenafil Fasted
Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
|
|---|---|---|
|
First Intervention Period
STARTED
|
6
|
6
|
|
First Intervention Period
COMPLETED
|
6
|
6
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
|
Washout Period (at Least 1 Day)
STARTED
|
6
|
6
|
|
Washout Period (at Least 1 Day)
COMPLETED
|
6
|
6
|
|
Washout Period (at Least 1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
6
|
6
|
|
Second Intervention Period
COMPLETED
|
6
|
6
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=12 Participants
Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dosePopulation: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Sildenafil 50 mg (Fasted)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
292.60 ng/mL
Standard Deviation 93.84
|
121.00 ng/mL
Standard Deviation 56.92
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dosePopulation: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Outcome measures
| Measure |
Sildenafil 50 mg (Fasted)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
813.20 ng*hr/mL
Standard Deviation 186.29
|
712.80 ng*hr/mL
Standard Deviation 245.58
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dosePopulation: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Sildenafil 50 mg (Fasted)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.625 hrs
Interval 0.25 to 1.5
|
4.000 hrs
Interval 0.5 to 6.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dosePopulation: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
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 |
Sildenafil 50 mg (Fasted)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=9 Participants
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
|
838.60 ng*hr/mL
Standard Deviation 197.20
|
804.00 ng*hr/mL
Standard Deviation 284.69
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dosePopulation: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Sildenafil 50 mg (Fasted)
n=12 Participants
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=9 Participants
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Decay Half Life (t1/2)
|
3.039 hrs
Standard Deviation 0.484
|
2.503 hrs
Standard Deviation 0.359
|
Adverse Events
Sildenafil 50 mg (Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sildenafil 50 mg (Fed)
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 |
Sildenafil 50 mg (Fasted)
n=12 participants at risk
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
|
Sildenafil 50 mg (Fed)
n=12 participants at risk
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
General disorders
Catheter site haematoma
|
16.7%
2/12
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%
0/12
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
|
0.00%
0/12
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.
|
8.3%
1/12
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
Dry throat
|
8.3%
1/12
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.
|
8.3%
1/12
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
Nasal congestion
|
8.3%
1/12
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.
|
16.7%
2/12
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12
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.
|
8.3%
1/12
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