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The main objective of this study is to assess the relative systemic bioavailability of diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with two diclofenac only products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, following topical administration.
In order to examine potential racial differences in pharmacokinetics (PK), the study population will be stratified 50:50, Caucasian versus Black people. With respect to the main objective, additionally a supportive analysis will be performed to investigate the influence of race on the intra-individual bioavailability ratios.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Sodium (A) | Experimental |
| |
| Diclofenac & Capsaicin (B) | Experimental |
| |
| Diclofenac Sodium Topical Gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium | Drug | twice daily |
| |
| Diclofenac & Capsaicin |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7) | AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented. | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7) | Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented. | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7) | tmax,ss, Time to maximum observed plasma concentration at steady state for diclofenac at day 7 (tmax,ss). Descriptive statistics by race are reported in addition. | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
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Inclusion Criteria:
Healthy males and females, 18 to 50 years (inclusive) at time of screening.
Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
Body mass not less than 50 kg for males and females.
Findings for medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be normal or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be not clinically significant for the purpose of the study.
Non-smokers.
Females, if:
Not of childbearing potential,
Of childbearing potential, the following conditions are to be met:
Written informed consent given for participation in the study.
Further inclusion criteria apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa) | Bloemfontein | 9301 | South Africa |
All subjects were screened for eligibility to participate in the trial. Subjects attended the trial site and it was ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
This was an open-label, randomized, 3-treatment periods (each of which included a multiple-dose period of 7 days [twice daily and only in the morning on Day 7] and two pharmacokinetic profile periods of 12 hours [Day 1] and 24 hours [Day 7]) separated by a wash out period of at least 7 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | A-B-R | Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A) Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 Including Washout 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2017 | Aug 31, 2018 |
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| Drug |
twice daily |
|
| Diclofenac Sodium Topical Gel | Drug | twice daily |
|
| Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State | Average plasma concentration (Cav,ss) calculated as AUC0-t,ss divided by τ=12 hours (τ is the duration of the dosing interval). Descriptive statistics by race are reported in addition. | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] | Percentage peak-trough fluctuation (%PTF) which was calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] for Diclofenac. Descriptive statistics by race are reported in addition. | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| FG001 | B-R-A | Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659) Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| FG002 | R-A-B | Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699) Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| FG003 | R-B-A | Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659) Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| FG004 | A-R-B | Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699) Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| FG005 | B-A-R | Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A) Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 Including Washout 2 |
|
|
| Period 3 |
|
|
Safety Population: All subjects who received at least one dose of investigational medicinal product (IMP) were included in the safety analysis of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A-B-R | Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A) Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG001 | B-R-A | Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659) Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG002 | R-A-B | Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699) Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG003 | R-B-A | Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659) Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG004 | A-R-B | Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699) Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG005 | B-A-R | Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A) Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7. All treatment periods were separated by a wash-out period of at least 7 days. |
| BG006 | 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 | Age at the time of signing informed consent form is presented. | Safety Population | Mean | Standard Deviation | Years |
| |||||||||||||
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | Safety Population | Count of Participants | Participants |
| ||||||||||||||
| Race (NIH/OMB) | Number of subjects is categorized for race data. Ethnicity data were not collected. Caucasian race is entered as White. | Safety Population | 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 | Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7) | AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented. | Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/millilitre (h*ng/mL) | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7) | Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented. | Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/millilitre (ng/mL) | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7) | tmax,ss, Time to maximum observed plasma concentration at steady state for diclofenac at day 7 (tmax,ss). Descriptive statistics by race are reported in addition. | Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations. | Posted | Median | Full Range | Hour (h) | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State | Average plasma concentration (Cav,ss) calculated as AUC0-t,ss divided by τ=12 hours (τ is the duration of the dosing interval). Descriptive statistics by race are reported in addition. | Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/ millilitre (ng/mL) | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] | Percentage peak-trough fluctuation (%PTF) which was calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] for Diclofenac. Descriptive statistics by race are reported in addition. | Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of Cav,ss (%) | Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration |
|
From first drug administration until individual subject's end of study, up to approximately 38 days.
Safety Population (All subjects who received at least one dose of study medication were included in the safety population) was used for safety analysis.
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 | Diclofenac 2% (A) | Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7. | 0 | 47 | 0 | 47 | 9 | 47 |
| EG001 | Diclofenac 2% + Capsaicin 0.075% (B) | Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7. | 0 | 46 | 0 | 46 | 44 | 46 |
| EG002 | Voltarol® 2.32% Gel (R) | Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7. | 0 | 47 | 0 | 47 | 3 | 47 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | 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 Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2017 | Aug 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| By race: Black |
|
|
| By race: Caucasian |
|
|
| ANOVA | Only the data for the comparison under investigation were included in the statistical analysis. | Geometric Mean (gMean) Ratio (%) | 85.56 | Standard Error of the Mean | 42.05 | 2-Sided | 90 | 74.11 | 98.77 | gMean Ratio=(B/A) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation | Equivalence | The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A. |
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
| OG002 | Voltarol® 2.32% Gel (R) | Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7. |
|
|
|
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
|
|
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7. |
|
|
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7. |
|
|