Phase 1
Completed N=30
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
Healthy
Source: ClinicalTrials.gov NCT01235195 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)] — 419.9; 442.1 nanogram hour per milliliter (ng*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)] |
419.9; 442.1 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
17.96; 19.03 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
5.00; 5.00 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
471.4; 493.8 | — |
| SECONDARY Residual Area Under the Concentration Time Curve [AUC(Res%)] |
— | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
25.45; 25.40 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01235195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.