To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
Phase 1
Completed
- Conditions
- Depression
- Interventions
- Registration Number
- NCT00913822
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories) Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories) 2 Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.) Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 22 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does the bioavailability of Cord Laboratories vs. Merrell Dow desipramine HCl tablets affect norepinephrine reuptake inhibition in depression?
What pharmacokinetic differences between generic and branded desipramine formulations impact therapeutic outcomes in major depressive disorder?
Do CYP2D6 polymorphisms influence response variability to desipramine hydrochloride in NCT00913822's Phase 1 study population?
What adverse event profiles emerged in Sandoz's desipramine bioequivalence trial compared to other tricyclic antidepressants?
How do desipramine's plasma concentration-time curves in NCT00913822 compare to venlafaxine or SSRIs for treatment-resistant depression?