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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

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ClinicalTrials.gov Identifier: NCT01235195
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : May 7, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Intervention Drug: sertraline hydrochloride
Enrollment 30

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule
Hide Arm/Group Description 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 Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
Period Title: First Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Washout Period of At Least 8 Days
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Second Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
30.4  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
7
  23.3%
Male
23
  76.7%
1.Primary Outcome
Title Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]
Hide Description AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: nanogram hour per milliliter (ng*h/mL)
419.9  (147.14) 442.1  (169.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline 50 mg Hard Gelatin Capsule, Sertraline 50 mg Film-Coated Tablet
Comments Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%) of adjusted means
Estimated Value 104.86
Confidence Interval (2-Sided) 90%
100.12 to 109.83
Estimation Comments Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
17.96  (5.0438) 19.03  (6.3319)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline 50 mg Hard Gelatin Capsule, Sertraline 50 mg Film-Coated Tablet
Comments Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%) of adjusted means
Estimated Value 105.34
Confidence Interval (2-Sided) 90%
98.46 to 112.69
Estimation Comments Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.
3.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: hours
5.00
(3.00 to 8.00)
5.00
(2.00 to 8.00)
4.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Hide Description 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 - ∞).
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
471.4  (189.86) 493.8  (204.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline 50 mg Hard Gelatin Capsule, Sertraline 50 mg Film-Coated Tablet
Comments Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%) of adjusted means
Estimated Value 106.1
Confidence Interval (2-Sided) 90%
100.16 to 112.39
Estimation Comments Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.
5.Secondary Outcome
Title Residual Area Under the Concentration Time Curve [AUC(Res%)]
Hide Description 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.
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Plasma Decay Half-Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description:
All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: hours
25.45  (3.9067) 25.40  (3.3831)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Hide Arm/Group Description All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
All-Cause Mortality
Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sertraline 50 mg Hard Gelatin Capsule Sertraline 50 mg Film-Coated Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   11/30 (36.67%)   13/30 (43.33%) 
Cardiac disorders     
Palpitations * 1  0/30 (0.00%)  1/30 (3.33%) 
Gastrointestinal disorders     
Abdominal distension * 1  0/30 (0.00%)  1/30 (3.33%) 
Diarrhoea * 1  5/30 (16.67%)  6/30 (20.00%) 
Eructation * 1  1/30 (3.33%)  0/30 (0.00%) 
Flatulence * 1  2/30 (6.67%)  3/30 (10.00%) 
Nausea * 1  2/30 (6.67%)  2/30 (6.67%) 
General disorders     
Catheter site haematoma * 1  1/30 (3.33%)  1/30 (3.33%) 
Catheter site swelling * 1  0/30 (0.00%)  1/30 (3.33%) 
Pyrexia * 1  1/30 (3.33%)  1/30 (3.33%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  0/30 (0.00%)  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/30 (0.00%)  1/30 (3.33%) 
Musculoskeletal stiffness * 1  1/30 (3.33%)  1/30 (3.33%) 
Nervous system disorders     
Dizziness * 1  1/30 (3.33%)  3/30 (10.00%) 
Headache * 1  1/30 (3.33%)  1/30 (3.33%) 
Hypoaesthesia * 1  0/30 (0.00%)  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/30 (3.33%)  0/30 (0.00%) 
Oropharyngeal pain * 1  1/30 (3.33%)  0/30 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01235195     History of Changes
Other Study ID Numbers: A0501097
First Submitted: November 3, 2010
First Posted: November 5, 2010
Results First Submitted: November 21, 2011
Results First Posted: May 7, 2012
Last Update Posted: May 23, 2012