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CompletedNCT00913783Updated Mar 28, 2017

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

A Phase 1 interventional study of Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals) and Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel) in Depression, sponsored by Sandoz. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Sandoz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.

02

Conditions studied

  • Depression

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Keywords

  • Antidepressant
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 36 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

    Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

  • Active comparator
    2

    Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

    Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Interventions

  • DrugClomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)
  • DrugAnafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)
06

What researchers measure

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 34 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913783
Lead sponsor
Sandoz
First posted
Jun 4, 2009
Start date
Nov 1992
Primary completion
Dec 1992
Completion
Dec 1992
Last update
Mar 28, 2017

Study contacts

Richard Lalonde, Pharm.D.
principal investigator · Phoenix International Life Science Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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