Pain ControlPhase 1NCT03418805

To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers

A Phase 1 study testing Advil Ibuprofen table 200 mg, Motrin IB Ibuprofen Tablets 200 mg and Ibuprofen CR Tablets 600 mg in people with Pain Control, run by Overseas Pharmaceuticals, Ltd. at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Pain Control
What is being tested?: Advil Ibuprofen table 200 mg, Motrin IB Ibuprofen Tablets 200 mg and Ibuprofen CR Tablets 600 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteTaiwan
Study dates: 11 Dec 2017to 31 Dec 2020
Phase: Phase 1
Are there results?: None posted in the registry

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 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects are 20 years of age or older.
Subjects whose body mass index (BMI) at screening is within a range of ≧18.5 kg/m2 and <25.0 kg/m2.
BMI = Body Weight (kg) / [Height (m)]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products).
Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs), chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests.
The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study.

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The Subject did not take any of the following medications in the specified durations:
Any medication within 14 days prior to the first dose of the study
Any enzyme inducer or inhibitor within 30 days prior to the first dose of the study
Subject understood and has signed the written informed consent form.

Who cannot join

Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the study
Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study
Subjects who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazole, fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study
The subject had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
The subject had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.

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The subject had a history of drug abuse or alcohol abuse.
Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first dose of the study and during the entire study period.
Subjects who are pregnant or lactating
For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 30 days prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.
Subjects who are inappropriate to participate in this study, as judged by the medical investigator or sub-investigator
Subjects with any contraindication to the use of test medications
Subjects who are carriers of hepatitis B virus, hepatitis C virus, or are syphilis (STS) positive, or human immunodeficiency virus (HIV) positive

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tri-Service General Hospital
Taipei

Other trials in Taiwan

About this study

Official title: A Randomized, 4-way Crossover Study to Evaluate the Food Effect and the Absorption Profile of Investigational Product of "Ibuprofen Controlled-Release Tablets 600 mg" in Comparison to the Reference Standard Ibuprofen Tablets 200 mg in Normal Healthy Volunteers

Read the detailed description

This randomized, open label, four-way crossover phase I study is to evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers.

This study will enroll at least 26 evaluable subjects. The duration for test and reference treatments is 24 to 32 hours with a washout period of at least 5 days after the last dose administration of study drugs. The total study will take at least 28 days.

Subjects who meet all eligible requirements for participating in the study will receive all following interventions according to one of the 4 random sequences by Williams design.

One tablet of IBUCR 600 mg under fasting condition
One tablet of IBUCR 600 mg under fed condition
IBUAdv with a 4-hour dosing interval for 3 tablets (3×200 mg, q4h) under fasting condition
IBUMot with a 4-hour doing interval for 3 tablets (3×200 mg, q4h) under fasting condition

The blood sampling schedule are described as follows:

-For subjects receiving IBUCR (fed and fasted): Before dose administration (blank) and at 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 18h, 24h, 28h, 32h post-dose (A total of 17 samples per subject)

-For subjects receiving IBUAdv/IBUMot (fasted): Before dose administration (blank) and at 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 8h, 8.5h, 9h, 9.5h, 10h, 10.5h, 11h, 12h, 16h, 20h, 24h post-dose (A total of 25 samples per subject)

Conditions: Pain Control
Being tested: Advil Ibuprofen table 200 mg, Motrin IB Ibuprofen Tablets 200 mg, Ibuprofen CR Tablets 600 mg
Keywords: Ibuprofen, Controlled-Release, pain control, Healthy Volunteers, Food Effect
Medical subject headings: Agnosia

What participants receive

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

Advil Ibuprofen table 200 mgDrug
Also called Advil® Ibuprofen Immediate-Release Tablet 200 mg
Administration of the comparator drug:
Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.
Motrin IB Ibuprofen Tablets 200 mgDrug
Also called Motrin® IB Ibuprofen Tablets 200 mg
Administration of the comparator drug:
Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.
Ibuprofen CR Tablets 600 mgDrug
Also called Ibuprofen Controlled-Release Tablet 600 mg
Administration of the investigational product:
Single oral dose of IBUCR, followed by 28 and 32 hours after the dose administration for fasted and fed studies, respectively

Study groups in NCT03418805
Study group	Role	What they receive
Ibuprofen CR Tablet 600 mg-fasting	Experimental	One tablet of IBUCR 600 mg under fasting condition Receives: Drug: Ibuprofen CR Tablets 600 mg
Ibuprofen CR Tablet 600 mg-fed	Experimental	One tablet of IBUCR 600 mg under fed condition Receives: Drug: Ibuprofen CR Tablets 600 mg
Advil Ibuprofen table 200 mg-fasting	Active comparator	IBUAdv with a 4-hour dosing interval for 3 tablets (3×200 mg, q4h) under fasting condition Receives: Drug: Advil Ibuprofen table 200 mg
Motrin IB Ibuprofen Tablets 200 mg-fasting	Active comparator	IBUMot with a 4-hour doing interval for 3 tablets (3×200 mg, q4h) under fasting condition Receives: Drug: Motrin IB Ibuprofen Tablets 200 mg

What is being measured

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

Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Area under the curve from time zero to infinity (AUC0-inf)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Peak concentration at each treatment period (Cmax,tp)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month

Secondary outcomes (11)

Peak concentration of the first dosing (Cmax)
Individual ibuprofen plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Individual ibuprofen plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Terminal half-life (T1/2)
Individual ibuprofen plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Mean residence time (MRT)
Individual ibuprofen plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
The maximum ibuprofen plasma concentration within 1 hour after the first dose administration (Cmax0-1h)
The Cmax0-1h will be observed. The mean Cmax0-1h of test and reference treatments under fasting condition will be calculated. Percentage of the test drug-treated subjects with higher or equal Cmax0-1h compared to that of receiving the reference treatments under fasting condition will be calculated.
Measured: 0.5h and 1h post-dose
The minimum ibuprofen plasma concentration within a time window of 1-12 hours after the first dose administration (Cmin1-12h)
The Cmin1-12h will be observed. The mean Cmin1-12h of test and reference treatments under fasting condition will be calculated.
Measured: 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h and 12h post-dose
The mean time to drop to the Cmin1-12h of reference treatments
For the plasma ibuprofen concentration of test treatments under fasting condition, the mean time to drop to the Cmin1-12h of reference treatments will be calculated.
Measured: 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 18h, 24h, 28h, 32h post-dose
Plasma ibuprofen concentrations at 8-hour (C8h) after the first dose administration
The C8h after the first dose administration will be observed (prior to the 8-hour dose administration for the reference treatments). The mean C8h of test and reference treatments under fasting condition will be calculated.
Measured: 8-hour after the first dose administration
Plasma ibuprofen concentrations at 12-hour (C12h) after the first dose administration
The C12h after the first dose administration will be observed. The mean C12h of test and reference treatments under fasting condition will be calculated.
Measured: 12-hour after the first dose administration
Percentage of the test drug-treated subjects with higher or equal C8h compared to that of receiving the reference treatments (before dose 3) under fasting condition
Measured: 1 month
Percentage of the test drug-treated subjects with higher or equal C12h compared to that of receiving the reference treatments under fasting condition
Measured: 1 month

Timeline

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

11 Dec 201731 Dec 2020

First posted1 Feb 2018
Study start11 Dec 2017
Primary completion31 Dec 2020
Study completion31 Dec 2020

Why it stopped: Sponsor's consideration of product development strategies

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain ControlStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03418805
Sponsor's protocol ID: OVEIBUZ20151221
Status last verified: Mar 2022
First submitted: 8 Jan 2018
Last updated: 1 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 4-way Crossover Study to Evaluate the Food Effect and the Absorption Profile of Investigational Product of "Ibuprofen Controlled-Release Tablets 600 mg" in Comparison to the Reference Standard Ibuprofen Tablets 200 mg in Normal Healthy Volunteers
ClinicalTrials.gov ID: NCT03418805
Acronym / sponsor ID: OVEIBUZ20151221
Conditions: Pain Control
Keywords: Ibuprofen, Controlled-Release, pain control, Healthy Volunteers, Food Effect
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's consideration of product development strategies
Enrolment: 31 participants (actual)
Lead sponsor: Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
Collaborators: Virginia Contract Research Organization Co., Ltd.
Study start: 11 Dec 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 1 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Subjects who meet all eligible requirements for participating in the study will receive all following interventions according to one of the 4 random sequences by Williams design.

One tablet of IBUCR 600 mg under fasting condition
One tablet of IBUCR 600 mg under fed condition
IBUAdv with a 4-hour dosing interval for 3 tablets (3×200 mg, q4h) under fasting condition
IBUMot with a 4-hour doing interval for 3 tablets (3×200 mg, q4h) under fasting condition

The blood sampling schedule are described as follows:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Ibuprofen CR Tablet 600 mg-fasting	Experimental	Drug: Ibuprofen CR Tablets 600 mgOne tablet of IBUCR 600 mg under fasting condition
Ibuprofen CR Tablet 600 mg-fed	Experimental	Drug: Ibuprofen CR Tablets 600 mgOne tablet of IBUCR 600 mg under fed condition
Advil Ibuprofen table 200 mg-fasting	Active comparator	Drug: Advil Ibuprofen table 200 mgIBUAdv with a 4-hour dosing interval for 3 tablets (3×200 mg, q4h) under fasting condition
Motrin IB Ibuprofen Tablets 200 mg-fasting	Active comparator	Drug: Motrin IB Ibuprofen Tablets 200 mgIBUMot with a 4-hour doing interval for 3 tablets (3×200 mg, q4h) under fasting condition

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects are 20 years of age or older.
Subjects whose body mass index (BMI) at screening is within a range of ≧18.5 kg/m2 and <25.0 kg/m2.
BMI = Body Weight (kg) / [Height (m)]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products).
Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs), chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests.

Key exclusion criteria (13 listed)

Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the study
Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study
Subjects who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazole, fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study
The subject had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.

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
Advil Ibuprofen table 200 mgAlso: Advil® Ibuprofen Immediate-Release Tablet 200 mgAdministration of the comparator drug: Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.	Drug	Advil Ibuprofen table 200 mg-fasting
Motrin IB Ibuprofen Tablets 200 mgAlso: Motrin® IB Ibuprofen Tablets 200 mgAdministration of the comparator drug: Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.	Drug	Motrin IB Ibuprofen Tablets 200 mg-fasting
Ibuprofen CR Tablets 600 mgAlso: Ibuprofen Controlled-Release Tablet 600 mgAdministration of the investigational product: Single oral dose of IBUCR, followed by 28 and 32 hours after the dose administration for fasted and fed studies, respectively	Drug	Ibuprofen CR Tablet 600 mg-fasting, Ibuprofen CR Tablet 600 mg-fed

Primary outcome

Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Area under the curve from time zero to infinity (AUC0-inf)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Peak concentration at each treatment period (Cmax,tp)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.

11 secondary outcomes

Peak concentration of the first dosing (Cmax)
Time frame: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Time frame: 1 month
Terminal half-life (T1/2)
Time frame: 1 month
Mean residence time (MRT)
Time frame: 1 month
The maximum ibuprofen plasma concentration within 1 hour after the first dose administration (Cmax0-1h)
Time frame: 0.5h and 1h post-dose
The minimum ibuprofen plasma concentration within a time window of 1-12 hours after the first dose administration (Cmin1-12h)
Time frame: 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h and 12h post-dose
The mean time to drop to the Cmin1-12h of reference treatments
Time frame: 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 18h, 24h, 28h, 32h post-dose
Plasma ibuprofen concentrations at 8-hour (C8h) after the first dose administration
Time frame: 8-hour after the first dose administration
Plasma ibuprofen concentrations at 12-hour (C12h) after the first dose administration
Time frame: 12-hour after the first dose administration
Percentage of the test drug-treated subjects with higher or equal C8h compared to that of receiving the reference treatments (before dose 3) under fasting condition
Time frame: 1 month
Percentage of the test drug-treated subjects with higher or equal C12h compared to that of receiving the reference treatments under fasting condition
Time frame: 1 month

Results and safety

The study was stopped early (reason given: Sponsor's consideration of product development strategies). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Apr 2022. 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 Taiwan. 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?

The study was stopped early (reason given: Sponsor's consideration of product development strategies). Results are not available in the source record.

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 curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last) (time frame: 1 month). The study lists 3 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 NCT03418805.

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 1 Apr 2022.