Bioequivalence of a Fixed Dose Combination Tablet Contain... | NCT02963701

Label	Type	Description	Intervention Names
Ibuprofen+Pseudoephedrine-HCl	Experimental	Fixed dose combination	Drug: Ibuprofen Drug: Pseudoephedrine-HCl
Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)	Active Comparator	Fixed Dose Combination	Drug: Ibuprofen Drug: Pseudoephedrine-HCl

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug	Fixed dose combination	Ibuprofen+Pseudoephedrine-HCl Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)

Measure	Description	Time Frame
Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)	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.	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.
Maximum Concentration of Ibuprofen in Plasma (Cmax).	This outcome is maximum measured concentration of the Ibuprofen in plasma	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.
Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).	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.	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.
Maximum Concentration of Pseudoephedrine in Plasma (Cmax).	This outcome is maximum measured concentration of the Pseudoephedrine in plasma	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.

Measure	Description	Time Frame
Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).	This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity	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.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Healthy males and females according to the following criteria:
Based upon a complete medical history, including physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
Age ≥21 to ≤50 years
Minimum weight 50kg - both males and females
Body Mass Index ≥18.5 to ≤29.9 kg/m2
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Male or female patients. Women of childbearing potential1 must be ready and able to use highly effective methods of birth control per International Committee on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly e.g. implants, injectables, combined hormonal contraceptives, intrauterine device, or surgical sterilisation (including hysterectomy). In addition to this, also a barrier method (e.g. male condom) will be required, if the female is not surgically sterilised. A list of contraception methods meeting these criteria is provided in the patient information. Abstaining from sexual activity (if this is the usual lifestyle of the subject) is considered an acceptable method of birth control.

Exclusion criteria:

Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance at the discretion of the investigator
Any evidence of a clinically relevant concomitant disease
Any relevant Gastrointestinal (e.g. ulcera, hernia, bleedings and spasm), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Any relevant surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders at the discretion of the investigator
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to first drug administration
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 14 days prior to randomisation
Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days as judged by the investigator
Alcohol abuse (average consumption of more than 2 units per day for females and more than 3 units per day for males)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration of the trial drug in this study)
Excessive physical activities within 1 week prior to randomisation or during the trial
Any laboratory value outside the reference range that is of clinical relevance at the discretion of the investigator
Inability to comply with dietary regimen of the study centre
Unwilling to avoid excessive sunlight exposure
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/corrected QT interval (QTc) within 14 days prior to administration or during the trial, and CYP2C8m substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half-lives (whichever is greater)
A marked baseline prolongation of the QTc B interval (e.g., repeated demonstration of a QTc B interval >450 ms)
A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)

Special exclusion criteria:

Subjects with history of bronchospasm, rhinitis or urticaria associated with Nonsteroidal anti-inflammatory drug (NSAID) - Asthma
Risk of or manifested narrow-angle glaucoma
Risk of urinary retention due to urethro-prostatic diseases / prostatic enlargement
Subjects with the rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase deficiency
Regular treatment with any systemically available medication (except hormonal contraceptives and hormonal replacement therapy e.g. estrogens, L-thyroxine)
Subjects, who report a frequent occurrence of migraine attacks
For female subjects of childbearing potential only:

Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion

No adequate contraception during the study including three months before first dosing until 2 month after study completion.
Lactation

Administrative reasons:

Subjects suspected or known not to follow instructions
Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study

The exclusion criteria are chosen to assure that subjects with specific risks for administration of the investigational medicinal products and subjects with conditions, which may have an impact on pharmacokinetic parameters, cannot be included

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

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 20, 2017	Jan 18, 2018

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00028 BG00128 BG00256

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 From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)

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.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour nano gram per milliliter (h*ng/mL)

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants	OG00055 OG00155

Title

Denominators

Categories

Title	Measurements
	OG000140500± 23.66 OG001139300± 19.30

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA	Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.			T/R Ratio (%)	99.16	Standard Deviation	8.49	2-Sided	90	96.52	101.89			The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).		Equivalence	A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%

Primary

Maximum Concentration of Ibuprofen in Plasma (Cmax).

This outcome is maximum measured concentration of the Ibuprofen in plasma

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Nano gram per milliliter (ng/mL)

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants

Primary

Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Primary

Maximum Concentration of Pseudoephedrine in Plasma (Cmax).

This outcome is maximum measured concentration of the Pseudoephedrine in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants

Secondary

Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Secondary

Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 extrapolated to infinity

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Secondary

AUC0-tz of R-Ibuprofen

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts

Secondary

AUC0-∞ of R-Ibuprofen

This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts

Secondary

Cmax of R-Ibuprofen

This outcome is maximum measured concentration of the R-Ibuprofen in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants

Secondary

AUC0-tz of S-Ibuprofen

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts

Secondary

AUC0-∞ of S-Ibuprofen

This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts

Secondary

Cmax of S-Ibuprofen

This outcome is maximum measured concentration of the S-Ibuprofen in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants

Secondary

S/R-ibuprofen Ratio for AUC0-tz

AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

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.

ID	Title	Description
OG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
OG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)

Units	Counts
Participants

ID	Term
D007052	Ibuprofen
D000082	Acetaminophen

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Reference Product (R)	Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)	0	55	0	55	0	55
EG001	Test Product (T)	Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)	0	56	0	56	0	56