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Trial record 24 of 329 for:    SERTRALINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 3 periods

Period 1:   First Intervention
    Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet   Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 

Period 2:   Washout Period of At Least 8 Days
    Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet   Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet   Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.4  (8.6) 
Gender 
[Units: Participants]
 
Female   7 
Male   23 


  Outcome Measures

1.  Primary:   Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

2.  Primary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

3.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

4.  Secondary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

5.  Secondary:   Residual Area Under the Concentration Time Curve [AUC(Res%)]   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

6.  Secondary:   Plasma Decay Half-Life (t1/2)   [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



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