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The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS | Experimental | Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. |
|
| Placebo TDS | Placebo Comparator | Matching placebo transdermal patches 5, 10, 20 and 2 * 20. |
|
| Moxifloxacin | Active Comparator | Moxifloxacin hydrochloride 400 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13 | Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | Baseline to Day 13 |
| The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13 | Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | Baseline to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP, Clinics | Austin | Texas | 78704 | United States |
During the initial screening visit, subjects were assessed for study eligibility through medical history, physical examination, vital signs, oxygen saturation, conventional 12-lead ECG, and laboratory tests. The investigator at the site examined the ECG telemetry to determine the subjects' eligibility.
02-Jul-2004 (first patient first visit) to 16-Dec-2004 (last patient last visit) at 1 site in the US (Austin, TX.)
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| ID | Title | Description |
|---|---|---|
| FG000 | BTDS | Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site. BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Matching placebo transdermal patch | Drug | Placebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20. |
|
| Avelox (moxifloxacin hydrochloride) tablet | Drug | Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13 |
|
|
| Baseline to Day 6 |
| The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | Baseline to Day 6 |
| The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec. | Baseline to Day 6 and Day 13 |
| The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec. | Baseline to Day 6 and Day 13 |
| The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec. | Baseline to Day 6 and Day 13 |
| The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec. | Baseline to Day 6 and Day 13 |
| FG001 | Placebo | Matching placebo transdermal patches. |
| FG002 | Moxifloxacin | Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BTDS | Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. |
| BG001 | Placebo | Matching placebo transdermal patches. |
| BG002 | Moxifloxacin | Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13 | Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded. | Posted | Least Squares Mean | Standard Deviation | QTci (msec) | Baseline to Day 13 |
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| Secondary | The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded. | Posted | Least Squares Mean | Standard Deviation | QTci (msec) | Baseline to Day 6 |
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| Primary | The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13 | Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded. | Posted | Least Squares Mean | Standard Deviation | QTci (msec) | Baseline to Day 13 |
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| Secondary | The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded. | Posted | Least Squares Mean | Standard Deviation | QTci (msec) | Baseline to Day 6 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded. | Posted | Least Squares Mean | Standard Deviation | QTcB (msec) | Baseline to Day 6 and Day 13 |
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| Secondary | The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded. | Posted | Least Squares Mean | Standard Deviation | QTcB (msec) | Baseline to Day 6 and Day 13 |
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| Secondary | The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded. | Posted | Least Squares Mean | Standard Deviation | QTcF (msec) | Baseline to Day 6 and Day 13 |
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| Secondary | The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 | QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec. | The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded. | Posted | Least Squares Mean | Standard Deviation | QTcF (msec) | Baseline to Day 6 and Day 13 |
|
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Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
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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 | BTDS | Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. | 0 | 44 | 43 | 44 | ||
| EG001 | Placebo | Matching placebo transdermal patches. | 0 | 44 | 31 | 44 | ||
| EG002 | Moxifloxacin | Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13. | 1 | 44 | 12 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced NOS | Surgical and medical procedures | MedDRA | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Vomiting NOS | Gastrointestinal disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Application site burning | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Application site erythema | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Application site irritation | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Application site pruritus | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Fatigue | General disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Systematic and nonsystematic assessments. |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Acne aggravated | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Application site paraesthesia | General disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
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| Rigors | General disorders | MedDRA | Systematic Assessment |
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| Thirst | General disorders | MedDRA | Systematic Assessment |
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| Abrasion NOS | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Poisoning NOS | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Bruxism | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
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BUP1011 is a safety study. The comparison of buprenorphine vs placebo on QTc (interval corrected for heart rate) values is the primary outcome.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000077266 | Moxifloxacin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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