Trial Outcomes & Findings for Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns (NCT NCT02078180)
NCT ID: NCT02078180
Last Updated: 2017-10-06
Results Overview
Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
4 days
Results posted on
2017-10-06
Participant Flow
Participant milestones
| Measure |
IR75, IR200, SR100, SR150, XL150, XL300
Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
IR75
|
30
|
|
Overall Study
IR100
|
31
|
|
Overall Study
SR100
|
31
|
|
Overall Study
SR150
|
32
|
|
Overall Study
XL 150
|
31
|
|
Overall Study
XL 300
|
32
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns
Baseline characteristics by cohort
| Measure |
IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300
n=34 Participants
Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
|
|---|---|
|
Age, Customized
<25 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
25-65 years
|
34 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 daysEach formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).
Outcome measures
| Measure |
Generic Bupropion SR100
n=30 Participants
One oral dose of generic bupropion SR100
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion SR150
n=32 Participants
One oral dose of generic bupropion SR150
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion XL150
n=30 Participants
One oral dose of generic bupropion XL150
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion IR75
n=30 Participants
One oral dose of generic bupropion IR75
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion IR100
n=31 Participants
One oral dose of generic bupropion IR100
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion XL300
n=30 Participants
One oral dose of generic bupropion XL300
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
|---|---|---|---|---|---|---|
|
Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage
|
706 h*nanogram/milliliter
Standard Deviation 304
|
1002 h*nanogram/milliliter
Standard Deviation 516
|
740 h*nanogram/milliliter
Standard Deviation 449
|
469 h*nanogram/milliliter
Standard Deviation 177
|
667 h*nanogram/milliliter
Standard Deviation 418
|
1356 h*nanogram/milliliter
Standard Deviation 637
|
SECONDARY outcome
Timeframe: 4 daysEach formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.
Outcome measures
| Measure |
Generic Bupropion SR100
n=30 Participants
One oral dose of generic bupropion SR100
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion SR150
n=32 Participants
One oral dose of generic bupropion SR150
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion XL150
n=30 Participants
One oral dose of generic bupropion XL150
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion IR75
n=30 Participants
One oral dose of generic bupropion IR75
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion IR100
n=31 Participants
One oral dose of generic bupropion IR100
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
Generic Bupropion XL300
n=30 Participants
One oral dose of generic bupropion XL300
generic bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
|
|---|---|---|---|---|---|---|
|
Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage
|
61 nanogram/milliliter
Standard Error 29
|
78 nanogram/milliliter
Standard Error 40
|
61 nanogram/milliliter
Standard Error 34
|
93 nanogram/milliliter
Standard Error 36
|
136 nanogram/milliliter
Standard Error 70
|
111 nanogram/milliliter
Standard Error 44
|
Adverse Events
IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300
n=34 participants at risk
Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention
|
|---|---|
|
Nervous system disorders
Headache
|
14.7%
5/34 • Number of events 5 • Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.
|
|
Eye disorders
Peripheral vision loss
|
2.9%
1/34 • Number of events 1 • Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.
|
|
Nervous system disorders
Dizzyness
|
2.9%
1/34 • Number of events 1 • Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34 • Number of events 1 • Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place