Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01879371
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Days): 30
• Patients Per Site Per Month: 36.5

Study Details

Study Description

Brief Summary

To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Ibuprofen+caffeine FDC; Drug: Ibuprofen (Nurofen Immedia®); Drug: Ibuprofen (Brufen®)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ibuprofen (Brufen®) film-coated tablet	Drug: Ibuprofen (Brufen®); oral dose
Active Comparator: Ibuprofen (Nurofen Immedia®) film-coated tablet	Drug: Ibuprofen (Nurofen Immedia®); oral dose
Experimental: Ibuprofen+caffeine fixed-dose-combination (FDC)	Drug: Ibuprofen+caffeine FDC; oral dose

Outcome Measures

Primary Outcome Measures

1. AUC(0-tz) [2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration]

   AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point

2. Cmax [2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration]

   Cmax: maximum measured concentration of Ibuprofen in plasma

Secondary Outcome Measures

1. AUC(0-inf) [2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration]

   AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male and female subjects

• Age 18 to 50 years

• Body mass index (BMI) 18.5 to 29.9 kg/m2

• Subjects must be able to understand and comply with study requirements

Exclusion criteria:

• Any relevant deviation from healthy conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1335.2.1 Boehringer Ingelheim Investigational Site	Ingelheim		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01879371
• Other Study ID Numbers: 1335.2; 2013-000990-66
• First Posted: Jun 17, 2013
• Last Update Posted: Nov 16, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Ibuprofen; Caffeine

Study Results

Participant Flow

Recruitment Details	36 healthy male and female subjects (at least a third of each sex) were recruited from the volunteers' pool of the Human Pharmacology centre of BI Pharma GmbH & Co. KG, Ingelheim, Germany.

Arm/Group Title	Ibu + Caf / Ibu Acid / Ibu Lysinate	Ibu + Caf / Ibu Lysinate / Ibu Acid	Ibu Acid / Ibu Lysinate/ Ibu + Caf	Ibu Acid/ Ibu + Caf / Ibu Lysinate	Ibu Lysinate/ Ibu + Caf / Ibu Acid	Ibu Lysinate / Ibu Acid / Ibu + Caf
Arm/Group Description	Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
Period Title: Overall Study
STARTED	6	6	6	6	6	6
COMPLETED	6	6	6	6	6	6
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Ibu + Caf / Ibu Acid / Ibu Lysinate	Ibu + Caf / Ibu Lysinate / Ibu Acid	Ibu Acid / Ibu Lysinate/ Ibu + Caf	Ibu Acid/ Ibu + Caf / Ibu Lysinate	Ibu Lysinate/ Ibu + Caf / Ibu Acid	Ibu Lysinate / Ibu Acid / Ibu + Caf	Total
Arm/Group Description	Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.	Total of all reporting groups
Overall Participants	6	6	6	6	6	6	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.7 (7.6)	36.3 (3.3)	42.8 (4.5)	40.2 (3.8)	37.5 (9.2)	38.3 (7.1)	39.0 (6.2)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	4 66.7%	3 50%	2 33.3%	2 33.3%	0 0%	15 41.7%
Male	2 33.3%	2 33.3%	3 50%	4 66.7%	4 66.7%	6 100%	21 58.3%

Outcome Measures

1. Primary Outcome

Title	AUC(0-tz)
Description	AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point
Time Frame	2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration

Outcome Measure Data

Analysis Population Description

Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.

Arm/Group Title	Ibuprofen + Caffeine (FDC) Tablet	Ibuprofen Acid Film-coated Tablet	Ibuprofen Lysinate Film-coated Tablet
Arm/Group Description	400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
Measure Participants	36	36	36
Geometric Mean (Geometric Coefficient of Variation) [μg*h/mL]	133 (22.2)	124 (19.4)	122 (19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Acid Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	107.85
	Confidence Interval	(2-Sided) 90%; 105.334 to 110.431
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Lysinate Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	109.48
	Confidence Interval	(2-Sided) 90%; 107.072 to 111.936
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.

2. Primary Outcome

Title	Cmax
Description	Cmax: maximum measured concentration of Ibuprofen in plasma
Time Frame	2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration

Outcome Measure Data

Analysis Population Description

PKS

Arm/Group Title	Ibuprofen + Caffeine (FDC) Tablet	Ibuprofen Acid Film-coated Tablet	Ibuprofen Lysinate Film-coated Tablet
Arm/Group Description	400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
Measure Participants	36	36	36
Geometric Mean (Geometric Coefficient of Variation) [μg/mL]	31.0 (17.2)	31.1 (22.5)	44.0 (20.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Acid Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	99.65
	Confidence Interval	(2-Sided) 90%; 93.874 to 105.776
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Lysinate Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	70.42
	Confidence Interval	(2-Sided) 90%; 67.087 to 73.928
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.

3. Secondary Outcome

Title	AUC(0-inf)
Description	AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity
Time Frame	2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration

Outcome Measure Data

Analysis Population Description

PKS

Arm/Group Title	Ibuprofen + Caffeine (FDC) Tablet	Ibuprofen Acid Film-coated Tablet	Ibuprofen Lysinate Film-coated Tablet
Arm/Group Description	400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h	Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
Measure Participants	35	36	36
Geometric Mean (Geometric Coefficient of Variation) [μg*h/mL]	135 (21.7)	127 (20.1)	125 (20.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Acid Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	106.50
	Confidence Interval	(2-Sided) 90%; 104.050 to 109.004
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen + Caffeine (FDC) Tablet, Ibuprofen Lysinate Film-coated Tablet
	Comments	The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (net)
	Estimated Value	108.59
	Confidence Interval	(2-Sided) 90%; 106.185 to 111.054
	Parameter Dispersion	Type: Value:
	Estimation Comments	The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.

Adverse Events

Time Frame	from up to 21 days prior to first drug administration until 30 days after end of trial, 64 days
Arm/Group Title	Ibuprofen + Caffeine (FDC) Tablet		Ibuprofen Acid Film-coated Tablet		Ibuprofen Lysinate Film-coated Tablet
Arm/Group Description	400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h		400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h		Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
All Cause Mortality
	Ibuprofen + Caffeine (FDC) Tablet		Ibuprofen Acid Film-coated Tablet		Ibuprofen Lysinate Film-coated Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ibuprofen + Caffeine (FDC) Tablet		Ibuprofen Acid Film-coated Tablet		Ibuprofen Lysinate Film-coated Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Ibuprofen + Caffeine (FDC) Tablet		Ibuprofen Acid Film-coated Tablet		Ibuprofen Lysinate Film-coated Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/36 (5.6%)		4/36 (11.1%)		1/36 (2.8%)
Nervous system disorders
Headache	2/36 (5.6%)		4/36 (11.1%)		1/36 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.