Trial Outcomes & Findings for Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects (NCT NCT02963701)
NCT ID: NCT02963701
Last Updated: 2018-09-27
Results Overview
This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.
COMPLETED
PHASE1
56 participants
Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.
2018-09-27
Participant Flow
This study was an Open-label, randomised, laboratory blind, single dose, two-way crossover, Phase I trial. A total of 56 healthy male and female subjects were randomised in the trial. Subjects were assigned randomly to one of two treatment sequences (Test-Reference, Reference-Test), before first drug administration.
Participant milestones
| Measure |
Treatment Sequence 1 (T-R)
Treatment sequence (Test-Reference): The subjects were administered orally under fasting condition first with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet and then with Reference product: 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets). Treatments were separated by a washout period of at least 5 days.
|
Treatment Sequence 2 (R-T)
Treatment sequence (Reference-Test): The subjects were administered orally under fasting condition first with Reference product : 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets) and then with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet. Treatments were separated by a washout period of at least 5 days.
|
|---|---|---|
|
Period 1 (Including Washout) (2 Days)
STARTED
|
28
|
28
|
|
Period 1 (Including Washout) (2 Days)
COMPLETED
|
27
|
28
|
|
Period 1 (Including Washout) (2 Days)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (2 Days)
STARTED
|
27
|
28
|
|
Period 2 (2 Days)
COMPLETED
|
27
|
28
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1 (T-R)
Treatment sequence (Test-Reference): The subjects were administered orally under fasting condition first with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet and then with Reference product: 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets). Treatments were separated by a washout period of at least 5 days.
|
Treatment Sequence 2 (R-T)
Treatment sequence (Reference-Test): The subjects were administered orally under fasting condition first with Reference product : 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets) and then with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet. Treatments were separated by a washout period of at least 5 days.
|
|---|---|---|
|
Period 1 (Including Washout) (2 Days)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1 (T-R)
n=28 Participants
Treatment sequence (Test-Reference): The subjects were administered orally under fasting condition first with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet and then with Reference product: 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets). Treatments were separated by a washout period of at least 5 days.
|
Treatment Sequence 2 (R-T)
n=28 Participants
Treatment sequence (Reference-Test): The subjects were administered orally under fasting condition first with Reference product : 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets) and then with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet. Treatments were separated by a washout period of at least 5 days.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 Years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
29.2 Years
STANDARD_DEVIATION 8.03 • n=7 Participants
|
28.8 Years
STANDARD_DEVIATION 7.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)
|
140500 Hour nano gram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.66
|
139300 Hour nano gram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.30
|
PRIMARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This outcome is maximum measured concentration of the Ibuprofen in plasma
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Maximum Concentration of Ibuprofen in Plasma (Cmax).
|
33580 Nano gram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.16
|
29940 Nano gram per milliliter (ng/mL)
Geometric Coefficient of Variation 20.80
|
PRIMARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 to the time of last quantifiable time point.
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).
|
2547 h*ng/mL
Geometric Coefficient of Variation 22.22
|
2540 h*ng/mL
Geometric Coefficient of Variation 22.45
|
PRIMARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This outcome is maximum measured concentration of the Pseudoephedrine in plasma
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Maximum Concentration of Pseudoephedrine in Plasma (Cmax).
|
320.4 ng/mL
Geometric Coefficient of Variation 22.09
|
327.4 ng/mL
Geometric Coefficient of Variation 25.28
|
SECONDARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
|
143000 h*ng/mL
Geometric Coefficient of Variation 22.88
|
141600 h*ng/mL
Geometric Coefficient of Variation 18.72
|
SECONDARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
|
2622 h*ng/mL
Geometric Coefficient of Variation 23.07
|
2614 h*ng/mL
Geometric Coefficient of Variation 23.65
|
SECONDARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
AUC0-tz of R-Ibuprofen
|
68520 h*ng/mL
Geometric Coefficient of Variation 28.08
|
65760 h*ng/mL
Geometric Coefficient of Variation 21.55
|
SECONDARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
AUC0-∞ of R-Ibuprofen
|
69420 h*ng/mL
Geometric Coefficient of Variation 27.76
|
66740 h*ng/mL
Geometric Coefficient of Variation 21.51
|
SECONDARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This outcome is maximum measured concentration of the R-Ibuprofen in plasma
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Cmax of R-Ibuprofen
|
18630 ng/mL
Geometric Coefficient of Variation 29.34
|
16910 ng/mL
Geometric Coefficient of Variation 21.98
|
SECONDARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
AUC0-tz of S-Ibuprofen
|
70290 h*ng/mL
Geometric Coefficient of Variation 24.90
|
71610 h*ng/mL
Geometric Coefficient of Variation 23.25
|
SECONDARY outcome
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
AUC0-∞ of S-Ibuprofen
|
72270 h*ng/mL
Geometric Coefficient of Variation 23.84
|
73460 h*ng/mL
Geometric Coefficient of Variation 22.21
|
SECONDARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population
This outcome is maximum measured concentration of the S-Ibuprofen in plasma
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
Cmax of S-Ibuprofen
|
15050 ng/mL
Geometric Coefficient of Variation 22.28
|
13020 ng/mL
Geometric Coefficient of Variation 22.36
|
SECONDARY outcome
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.Population: Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population.
AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen
Outcome measures
| Measure |
Reference Product (R)
n=55 Participants
Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
|
Test Product (T)
n=55 Participants
Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
|
|---|---|---|
|
S/R-ibuprofen Ratio for AUC0-tz
|
1.026 Ratio
Geometric Coefficient of Variation 23.26
|
1.089 Ratio
Geometric Coefficient of Variation 23.30
|
Adverse Events
Reference Product (R)
Test Product (T)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Other - 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.
- Publication restrictions are in place
Restriction type: OTHER