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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

Tracking Information
First Submitted Date  ICMJE November 3, 2010
First Posted Date  ICMJE November 5, 2010
Results First Submitted Date  ICMJE November 21, 2011
Results First Posted Date  ICMJE May 7, 2012
Last Update Posted Date May 23, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 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 ]
    AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
  • Area under the concentration time curve (AUC0-72) of sertraline hydrochloride 50 mg film-coated tablets and sertraline hydrochloride 50 mg hard gelatin capsules. [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
  • Peak plasma concentration (Cmax) of sertraline hydrochloride 50 mg film-coated tablets and sertraline hydrochloride 50 mg hard gelatin capsules. [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
Change History Complete list of historical versions of study NCT01235195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 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 ]
  • 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 ]
    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 - ∞).
  • 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 ]
    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.
  • 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 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
  • Time at maximum concentration (Tmax) of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
  • Area under the concentration time curve [AUC(0-∞)] of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
  • Residual area under the concentration time curve [AUC(res%)] of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
  • half-life (t1/2) of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Sertraline Hydrochloride 50 mg Film-Coated Tablets To Sertraline Hydrochloride 50 mg Hard Capsules Under Fasted Conditions
Brief Summary This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: sertraline hydrochloride
    50 mg capsule, single-dose
    Other Name: Zoloft
  • Drug: sertraline hydrochloride
    50 mg tablet, single-dose
    Other Name: Zoloft
Study Arms  ICMJE
  • Active Comparator: Sertraline 50 mg capsules
    Intervention: Drug: sertraline hydrochloride
  • Active Comparator: Sertraline 50 mg tablet
    Intervention: Drug: sertraline hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01235195
Other Study ID Numbers  ICMJE A0501097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP