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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: sertraline hydrochloride (Drug); sertraline hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Residual Area Under the Concentration Time Curve [AUC(Res%)]

Plasma Decay Half-Life (t1/2)

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2010
Last updated: May 17, 2012

Page last updated: August 23, 2015

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