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The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Imipramine Pamoate, then Tofranil-PM | Active Comparator | First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) |
|
| First Tofranil PM, then imipramine pamoate | Active Comparator | First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipramine Pamoate | Drug | 75 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence Determined by Statistical Comparison Cmax | Blood samples were collected pre-dose and at intervals over 120 hours after each dose | 33 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soran Hong, M.D. | Novum Pharmaceutical Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Houston | Texas | 77042-4712 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Normal healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | First Tofranil PM, Then Imipramine Pamoate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bioequivalence Determined by Statistical Comparison Cmax | Blood samples were collected pre-dose and at intervals over 120 hours after each dose | Posted | Mean | Standard Deviation | ng/mL | 33 Days |
|
33 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anton (Tony) Amann, PhD., Executive Director, DRAMA | Roxane Laboratories, Inc. | 614-272-4785 | tony.amann@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 |
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