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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00913237
Enrollment
36
Registered
2009-06-04
Start date
1987-07-31
Completion date
1987-08-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Antidepressant

Brief summary

To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.

Interventions

DRUGDesipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
DRUGDesipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)

Sponsors

Sandoz
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Bioequivalence based on AUC and Cmax28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026