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Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01107353
Enrollment
39
Registered
2010-04-20
Start date
2008-08-31
Completion date
2008-09-30
Last updated
2018-02-05

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

Conditions

Depression

Brief summary

The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

Interventions

DRUGImipramine Pamoate

75 mg capsule

Sponsors

Roxane Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to imipramine pamoate or any comparable or similar product.

Design outcomes

Primary

MeasureTime frameDescription
Bioequivalence Determined by Statistical Comparison Cmax33 DaysBlood samples were collected pre-dose and at intervals over 120 hours after each dose

Countries

United States

Participant flow

Participants by arm

ArmCount
First Imipramine Pamoate, Then Tofranil-PM
First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) Imipramine Pamoate: 75 mg capsule
20
First Tofranil PM, Then Imipramine Pamoate
First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period) Imipramine Pamoate: 75 mg capsule
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPositive Drug Screen10

Baseline characteristics

CharacteristicFirst Imipramine Pamoate, Then Tofranil-PMTotalFirst Tofranil PM, Then Imipramine Pamoate
Age, Continuous28.41 years
STANDARD_DEVIATION 7.65
28.41 years
STANDARD_DEVIATION 7.65
28.41 years
STANDARD_DEVIATION 7.65
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
19 Participants36 Participants17 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
0 Participants3 Participants3 Participants
Region of Enrollment
United States
20 participants40 participants20 participants
Sex: Female, Male
Female
6 Participants13 Participants7 Participants
Sex: Female, Male
Male
14 Participants27 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Bioequivalence Determined by Statistical Comparison Cmax

Blood samples were collected pre-dose and at intervals over 120 hours after each dose

Time frame: 33 Days

ArmMeasureValue (MEAN)Dispersion
First Imipramine Pamoate, Then Tofranil-PMBioequivalence Determined by Statistical Comparison Cmax11.5 ng/mLStandard Deviation 7.48
First Tofranil PM, Then Imipramine PamoateBioequivalence Determined by Statistical Comparison Cmax11.3 ng/mLStandard Deviation 7.03

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