Trial Outcomes & Findings for Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions (NCT NCT01107353)
NCT ID: NCT01107353
Last Updated: 2018-02-05
Results Overview
Blood samples were collected pre-dose and at intervals over 120 hours after each dose
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
33 Days
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Positive Drug Screen
|
1
|
0
|
Baseline Characteristics
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Baseline characteristics by cohort
| Measure |
First Imipramine Pamoate, Then Tofranil-PM
n=20 Participants
First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule
|
First Tofranil PM, Then Imipramine Pamoate
n=20 Participants
First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.41 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
28.41 years
STANDARD_DEVIATION 7.65 • n=7 Participants
|
28.41 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 33 DaysBlood samples were collected pre-dose and at intervals over 120 hours after each dose
Outcome measures
| Measure |
First Imipramine Pamoate, Then Tofranil-PM
n=19 Participants
First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule
|
First Tofranil PM, Then Imipramine Pamoate
n=19 Participants
First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule
|
|---|---|---|
|
Bioequivalence Determined by Statistical Comparison Cmax
|
11.5 ng/mL
Standard Deviation 7.48
|
11.3 ng/mL
Standard Deviation 7.03
|
Adverse Events
First Imipramine Pamoate, Then Tofranil-PM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
First Tofranil PM, Then Imipramine Pamoate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anton (Tony) Amann, PhD., Executive Director, DRAMA
Roxane Laboratories, Inc.
Phone: 614-272-4785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60