Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To establish the bioequivalence and adhesion properties of transdermal clonidine prepared with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catapres-TTS-3 crossover 1 | Experimental | subject to receive 0.3 mg/24 hr Catapres-TTS-3 Oppanol (T1) first, followed by Catapres-TTS-3 Vistanex (R1) |
|
| Catapres-TTS-3 crossover 2 | Experimental | subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex (R1) first, followed by Catapres-TTS-3 Oppanol (T1) |
|
| Catapres-TTS-1 crossover 1 | Experimental | subject to receive 0.1 mg/24 hr Catapres-TTS-1 with Oppanol (T2) and Vistanex (R2) simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catapres-TTS-1 | Drug | Catapres-TTS-1 Oppanol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h) | AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration |
| Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7) | Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity) | AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
Not provided
Inclusion criteria:
A complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Age greater than or equal to 18 and Age less than or equal to 65 years
BMI greater than or equal to 18.5 and BMI less than or equal to 32.0 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study
Male subjects, or females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 253.2486.1 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
Not provided
This study was conducted in three separate groups.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex | Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1(7 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intervention 1: Catapres-TTS-3 |
| Drug |
Catapres-TTS-3 Oppanol |
|
| Intervention 1: Catapres-TTS-3 | Drug | Catapres-TTS-3 Oppanol |
|
| Intervention 2: Catapres-TTS-3 | Drug | Catapres-TTS-3 Vistanex |
|
| Catapres-TTS-1 | Drug | Catapres-TTS-1 Vistanex |
|
| Intervention 2: Catapres-TTS-3 | Drug | Catapres-TTS-3 Vistanex |
|
| Cmax (Maximum Concentration of Clonidine in Plasma) | Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
| FG001 |
| Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol |
Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Period 1(7 Days) |
|
| Treatment Period 2 (7 Days) |
|
| Washout Period 2 (3 Days) |
|
| Treatment Period 3 (7 Days) |
|
|
All enrolled subjects in the trial were treated and were included in the treated set (TS).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch. In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1). |
| 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 |
|
| 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 | AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h) | AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7) | Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity) | AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax (Maximum Concentration of Clonidine in Plasma) | Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively. | PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration |
|
|
From patch administration until at most 7 days after patch removal, i.e., up to 14 days
Not provided
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 | TTS-3: Oppanol® (T1) | Administration of TTS-3 with Oppanol® | 0 | 57 | 46 | 57 | ||
| EG001 | TTS-3: Vistanex™ (R1) | Administration of TTS-3 with Vistanex™ | 0 | 57 | 45 | 57 | ||
| EG002 | TTS-1: Vistanex™ (R2) + Oppanol® (T2) | Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™ | 0 | 56 | 23 | 56 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Application site papules | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.
|
|
|
|
|
|