Healthy VolunteersPhase 1NCT02963701

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

A Phase 1 study testing Ibuprofen and Pseudoephedrine-HCl in people with Healthy Volunteers, run by Boehringer Ingelheim at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to the analytes, ibuprofen and… Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Ibuprofen and Pseudoephedrine-HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteSouth Africa
Study dates: 20 Dec 2016to 8 Feb 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 38Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)
Bloemfontein, 9301

Other trials in South Africa

About this study

Official title: 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® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 Healthy Male and Female Subjects (Open-label, Randomized, Laboratory Blind, Single Dose, Two-way Crossover, Phase I Trial).

Secondary objective To assess the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to R- and S-ibuprofen (enantiomers of ibuprofen).

Conditions: Healthy Volunteers
Being tested: Ibuprofen, Pseudoephedrine-HCl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IbuprofenDrug
Fixed dose combination
Pseudoephedrine-HClDrug
Fixed dose combination

Study groups in NCT02963701
Study group	Role	What they receive
Ibuprofen+Pseudoephedrine-HCl	Experimental	Fixed dose combination Receives: Drug: Ibuprofen; Drug: Pseudoephedrine-HCl
Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)	Active comparator	Fixed Dose Combination Receives: Drug: Ibuprofen; Drug: Pseudoephedrine-HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.

Secondary outcomes (9)

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
Measured: 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 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
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
Cmax of R-Ibuprofen
This outcome is maximum measured concentration of the R-Ibuprofen in plasma
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
Cmax of S-Ibuprofen
This outcome is maximum measured concentration of the S-Ibuprofen in plasma
Measured: 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.
S/R-ibuprofen Ratio for AUC0-tz
AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20168 Feb 2017

First posted15 Nov 2016 (estimated)
Study start20 Dec 2016
Primary completion31 Jan 2017
Study completion8 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02963701
Sponsor's protocol ID: 1024.9
Status last verified: Jan 2018
First submitted: 10 Nov 2016
Last updated: 27 Sep 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 Healthy Male and Female Subjects (Open-label, Randomized, Laboratory Blind, Single Dose, Two-way Crossover, Phase I Trial).
ClinicalTrials.gov ID: NCT02963701
Acronym / sponsor ID: 1024.9
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Dec 2016 (actual)
Primary completion: 31 Jan 2017 (actual)
Study completion: 8 Feb 2017 (actual)
First posted: 15 Nov 2016 (estimated)
Results: Posted 27 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Ibuprofen+Pseudoephedrine-HCl	Experimental	Drug: Ibuprofen, Drug: Pseudoephedrine-HClFixed dose combination
Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)	Active comparator	Drug: Ibuprofen, Drug: Pseudoephedrine-HClFixed Dose Combination

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (38 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IbuprofenFixed dose combination	Drug	Ibuprofen+Pseudoephedrine-HCl, Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)
Pseudoephedrine-HClFixed dose combination	Drug	Ibuprofen+Pseudoephedrine-HCl, Ibuprofen+Pseudoephedrine-HCl (RhinAdvil®)

Primary outcome

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

9 secondary outcomes

Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Time frame: 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 Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Time frame: 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.
AUC0-tz of R-Ibuprofen
Time frame: 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.
AUC0-∞ of R-Ibuprofen
Time frame: 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.
Cmax of R-Ibuprofen
Time frame: 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.
AUC0-tz of S-Ibuprofen
Time frame: 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.
AUC0-∞ of S-Ibuprofen
Time frame: 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.
Cmax of S-Ibuprofen
Time frame: 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.
S/R-ibuprofen Ratio for AUC0-tz
Time frame: 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.

Results and safety

Results posted to the registry on 27 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1 (T-R)	28	27
Treatment Sequence 2 (R-T)	28	28

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

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: Hour nano gram per milliliter (h*ng/mL)

Measure	Reference Product (R) n = 55	Test Product (T) n = 55
Value	140500 (23.66)	139300 (19.30)

Reference Product (R) vs Test Product (T): T/R Ratio (%): 99.16 (90% CI 96.52 to 101.89), ANOVA

Population analysed: 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

Primary outcome: Maximum Concentration of Ibuprofen in Plasma (Cmax).

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: Nano gram per milliliter (ng/mL)

Measure	Reference Product (R) n = 55	Test Product (T) n = 55
Value	33580 (26.16)	29940 (20.80)

Reference Product (R) vs Test Product (T): T/R Ratio (%): 89.16 (90% CI 83.88 to 94.76), ANOVA

Population analysed: 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

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

Measure	Reference Product (R) n = 55	Test Product (T) n = 55
Value	2547 (22.22)	2540 (22.45)

Reference Product (R) vs Test Product (T): T/R Ratio (%): 99.75 (90% CI 95.73 to 103.95), ANOVA

Primary outcome: Maximum Concentration of Pseudoephedrine in Plasma (Cmax).

Measure	Reference Product (R) n = 55	Test Product (T) n = 55
Value	320.4 (22.09)	327.4 (25.28)

Reference Product (R) vs Test Product (T): T/R Ratio (%): 102.16 (90% CI 97.30 to 107.27), ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration till 7 days after last drug administration; up to 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference Product (R)	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Test Product (T)	0 of 56 (0%)	0 of 56 (0%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen and Pseudoephedrine-HCl in people with Healthy Volunteers, run by Boehringer Ingelheim at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.