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The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.
The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Rest | Experimental | BTDS 10 with no application site rest period prior to application of second BTDS |
|
| 7-Day Rest | Experimental | BTDS 10 with 7-day rest period prior to application of second BTDS |
|
| 14-Day Rest | Experimental | BTDS 10 with 14-day rest period prior to application of second BTDS |
|
| 21-Day Rest | Experimental | BTDS 10 with 21-day rest period prior to application of second BTDS |
|
| 28-Day Rest | Experimental | BTDS 10 with 28-day rest period prior to application of second BTDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Period 1: AUC0-3d | Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)]. | 0 to 3 days (72 hours) |
| Period 2: AUC0-3d. | Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d. AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). | 0 to 3 days |
| Period 1: Cmax0-3d | Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug. | 0 to 3 days |
| Period 2: Cmax0-3d | Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug. | 0 to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Period 1: AUC0-7d. | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. | 0 to 7 days |
| Period 2: AUC0-7d |
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Inclusion Criteria Include:
Exclusion Criteria Include:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Department of Pharmacology | Columbus | Ohio | 43210 | United States |
Subjects were assigned into 1 of 5 treatment groups with different recovery periods, ranging from 0 to 4 weeks. For the 5 treatment groups, the rest period was 0, 7, 14, 21, or 28 days, respectively, between the removal of the first buprenorphine transdermal system (BTDS) and placement of the second BTDS in exactly the same location.
19-Nov-2000 (first patient, first visit) to 18-Mar-2001 (last patient, last visit) at 1 center in the US, Columbus, OH.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. |
| 0 to 7 days |
| Period 1: Cmax0-7 | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. | 0 to 7 days |
| Period 2: Cmax0-7d | Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. | 0 to 7 days |
| Period 1: Tmax0-7d. | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax. | 0 to 7days |
| Period 2: Tmax0-7d. | Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax. | 0 to 7 days |
| FG001 |
| 7-Day Rest |
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location. |
| FG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| FG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| FG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location. |
| BG001 | 7-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location. |
| BG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| BG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| BG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Period 1: AUC0-3d | Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)]. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL*h | 0 to 3 days (72 hours) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Period 2: AUC0-3d. | Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d. AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL*h | 0 to 3 days |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Period 1: Cmax0-3d | Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL | 0 to 3 days |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Period 2: Cmax0-3d | Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL | 0 to 3 days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 1: AUC0-7d. | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL*h | 0 to 7 days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 2: AUC0-7d | Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL*h | 0 to 7 days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 1: Cmax0-7 | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL | 0 to 7 days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 2: Cmax0-7d | Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | pg/mL | 0 to 7 days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 1: Tmax0-7d. | Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | hour | 0 to 7days |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Period 2: Tmax0-7d. | Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax. | Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications. | Posted | Mean | Standard Error | hour | 0 to 7 days |
|
All adverse events, whether spontaneously reported or elicited on direct questioning, that occurred after administration of the first dose of study drug and on or before the final visit were reported on the adverse event form.
AEs were learned of by spontaneous reports and subject interview.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location. | 0 | 13 | 11 | 13 | ||
| EG001 | 7-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location. | 1 | 14 | 14 | 14 | ||
| EG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. | 0 | 15 | 13 | 15 | ||
| EG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. | 0 | 14 | 10 | 14 | ||
| EG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. | 0 | 14 | 11 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Hepatobiliary disorders | COSTART | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis | Cardiac disorders | COSTART | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Asthenia | General disorders | COSTART | Systematic Assessment |
| |
| Headache | General disorders | COSTART | Systematic Assessment |
| |
| Thirst | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Nervousness | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Vertigo | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Thinking abnormally | Psychiatric disorders | COSTART | Systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Prutitus at site | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | COSTART | Systematic Assessment |
| |
| Accidental injury | General disorders | COSTART | Systematic Assessment |
| |
| Back pain | General disorders | COSTART | Systematic Assessment |
| |
| Chest pain substernal | General disorders | COSTART | Systematic Assessment |
| |
| Infection | General disorders | COSTART | Systematic Assessment |
| |
| Infection bacterial | General disorders | COSTART | Systematic Assessment |
| |
| Pain | General disorders | COSTART | Systematic Assessment |
| |
| Reaction unevaluable | General disorders | COSTART | Systematic Assessment |
| |
| Electrocardiogram abnormal | Cardiac disorders | COSTART | Systematic Assessment |
| |
| Palpitation | Cardiac disorders | COSTART | Systematic Assessment |
| |
| Vasodilatation | Cardiac disorders | COSTART | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
| |
| Bilirubinemia | Metabolism and nutrition disorders | COSTART | Systematic Assessment |
| |
| Agitation | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Tremor | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Cough increased | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Erythema at site | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
| |
| Other site reactions | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
| |
| Amblyopia | Eye disorders | COSTART | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | COSTART | Systematic Assessment |
| |
| Photophobia | Eye disorders | COSTART | Systematic Assessment |
| |
| Abnormal ejaculation | Renal and urinary disorders | COSTART | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | COSTART | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | COSTART | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director, Clinical Pharmacology | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Unknown or Not Reported |
|
| OG002 |
| 14-Day Rest |
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
|
|
| OG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
|
|
| OG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
|
|
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
|
|
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
|
|
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
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Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
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| OG002 |
| 14-Day Rest |
Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
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| OG002 | 14-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG003 | 21-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. |
| OG004 | 28-Day Rest | Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. |
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