Trial Outcomes & Findings for A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions (NCT NCT01235195)
NCT ID: NCT01235195
Last Updated: 2021-01-27
Results Overview
AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet
Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
|
Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule
Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
15
|
15
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of At Least 8 Days
STARTED
|
15
|
15
|
|
Washout Period of At Least 8 Days
COMPLETED
|
15
|
15
|
|
Washout Period of At Least 8 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
15
|
15
|
|
Second Intervention
COMPLETED
|
15
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=30 Participants
Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
|
|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.
AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).
Outcome measures
| Measure |
Sertraline 50 mg Hard Gelatin Capsule
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]
|
419.9 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 147.14
|
442.1 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 169.20
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants.
Outcome measures
| Measure |
Sertraline 50 mg Hard Gelatin Capsule
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
17.96 nanogram per milliliter (ng/mL)
Standard Deviation 5.0438
|
19.03 nanogram per milliliter (ng/mL)
Standard Deviation 6.3319
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants.
Outcome measures
| Measure |
Sertraline 50 mg Hard Gelatin Capsule
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.00 hours
Interval 3.0 to 8.0
|
5.00 hours
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants.
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 |
Sertraline 50 mg Hard Gelatin Capsule
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
471.4 ng*h/mL
Standard Deviation 189.86
|
493.8 ng*h/mL
Standard Deviation 204.90
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.
AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Sertraline 50 mg Hard Gelatin Capsule
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 Participants
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
25.45 hours
Standard Deviation 3.9067
|
25.40 hours
Standard Deviation 3.3831
|
Adverse Events
Sertraline 50 mg Hard Gelatin Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Sertraline 50 mg Film-Coated Tablet
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 |
Sertraline 50 mg Hard Gelatin Capsule
n=30 participants at risk
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
|
Sertraline 50 mg Film-Coated Tablet
n=30 participants at risk
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
5/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
6/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Catheter site haematoma
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Catheter site swelling
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant 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