To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions

Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913952

Enrollment

Registered

2009-06-04

Start date

1994-04-30

Completion date

1994-06-30

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 Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.

Interventions

DRUGGeneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions

DRUGGeneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

DRUGBasel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 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

Measure	Time frame
Bioequivalence based on AUC and Cmax	53 days

Outcome results

None listed

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