CompletedNCT05329454Updated Apr 15, 2022

To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg

A Phase 1 interventional study of Ibuprofen Tablets in Chronic Pain, sponsored by Overseas Pharmaceuticals, Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-15.

Sponsored by Overseas Pharmaceuticals, Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2021, 5 years 8 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy volunteers

Primary objective:

To evaluate the food effect of IBUMR and its bioavailability of single and multiple doses compared with reference drugs in normal healthy volunteers.

Secondary objectives:

To determine and compare the single and multiple dose PK profiles of IBUMR and reference drugs.
To identify the effect duration for IBUMR after dose administration by detecting ibuprofen concentrations in plasma.
To evaluate the safety profile of single and multiple doses of IBUMR.

Read the detailed description

This study consists of 3 treatment periods as below. For Treatment A and Treatment B, single- and multiple-dose stages are included.

Treatment A:

One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 8 doses.

Treatment B:

One tablet of IBURed-800mg will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed-600mg every 8 hours for a total of 12 doses.

Treatment C:

Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).

A minimum of 3-day washout interval will be introduced across the 3 treatment periods. Subjects will be required to be fasted for at least 10 hours prior to the administration of morning doses.

Conditions studied

Chronic Pain

Browse trials for

Chronic Pain 2,998

Keywords

Ibuprofen Modified-Release Tablets
Overseas Pharmaceuticals
pain relief

In context

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 2,209 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Overseas Pharmaceuticals, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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) and non-steroidal anti-inflammatory drugs (NSAIDs).
Subjects who are judged to be in good health by the investigator based upon the results of physical examination (PE), vital signs, and routine laboratory tests.
The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study.
The subject did not take any of the following medications in the specified durations:
Any systemically absorbed medication within 14 days (excluding vitamins, food supplements and hormone contraceptives not ibuprofen drug interactions) prior to the first dose of the study
Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazolem fluconazole, itraconazole) within 30 days prior to the first dose of the study.
Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form by the subject or legal representative if he/she is under the statutory age of consent as per the local authority.

Exclusion criteria

Exclusion Criteria:

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 or coronary artery bypass graft.
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 have participated in investigational drug trials and took any investigational drug within 60 days prior to the first does of the study.
Subjects had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria.
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.
Subjects who have been tested positive for the following tests:
Human immunodeficiency virus (HIV)
Hepatitis B virus (HBV)
Hepatitis C virus (HCV)
Treponema pallidum (STS test)
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 with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the investigator would not permit to participate in the study.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Treatment ABC
Receive the investigational product and active comparator in a sequence of treatment A, treatment B and treatment C.
Drug: Ibuprofen Tablets
Experimental
Treatment ACB
Receive the investigational product and active comparator in a sequence of treatment A, treatment C and treatment B.
Drug: Ibuprofen Tablets
Experimental
Treatment BAC
Receive the investigational product and active comparator in a sequence of treatment B, treatment A and treatment C.
Drug: Ibuprofen Tablets
Experimental
Treatment BCA
Receive the investigational product and active comparator in a sequence of treatment B, treatment C and treatment A.
Drug: Ibuprofen Tablets
Experimental
Treatment CAB
Receive the investigational product and active comparator in a sequence of treatment C, treatment A and treatment B.
Drug: Ibuprofen Tablets
Experimental
Treatment CBA
Receive the investigational product and active comparator in a sequence of treatment C, treatment B and treatment A.
Drug: Ibuprofen Tablets

Interventions

DrugIbuprofen Tablets
Treatment A: One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 7 doses. Treatment B: One tablet of IBURed will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed every 8 hours for a total of 10 doses. Treatment C: Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).

What researchers measure

Primary outcomes

Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to the last measurable concentration (AUCL)
Time frame: After collecting blood samples from the last participant, up to 30 days
Comparison of single-dose and multi-dose bioavailability of IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of the peak concentration (Cmax)
Time frame: After collecting blood samples from the last participant, up to 30 days
Comparison of single - and multi-dose bioavailability of IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to infinity (AUCinf).
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters
To assess the food effect of IBUMR in the PK parameters including Cmax
Time frame: After collecting blood samples from the last participant, up to 30 days
To evaluate the food effect of IBUMR on PK parameters
To assess the food effect of IBUMR in the PK parameters including time to reach peak concentration (Tmax)
Time frame: After collecting blood samples from the last participant, up to 30 days
To evaluate the food effects of IBUMR on PK parameters
To assess the food effect of IBUMR in the PK parameters including AUCL
Time frame: After collecting blood samples from the last participant, up to 30 days
Evaluate the food effect of IBUMR in PK parameters
To assess the food effect of IBUMR in the PK parameters including AUCinf
Time frame: After collecting blood samples from the last participant, up to 30 days
Determine the food effect of IBUMR in PK parameters
To assess the food effect of IBUMR in the PK parameters including elimination half-life (t1/2)
Time frame: After collecting blood samples from the last participant, up to 30 days

Secondary outcomes

Single-dose PK measures
\-- Time to reach peak concentration (Tmax)
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK method
\-- Area under the concentration-time curve within time span t1 to t2 (AUCt1→t2)
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK
\-- Area under the concentration-time curve extrapolated from the last detectable sampling time point to infinity as a percentage of total AUC (AUCextrap)
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK step
\-- Elimination half-life (t1/2)
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK design
\-- Apparent oral clearance (CL/F)
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK moves
\-- Apparent volume of distribution after oral administration (Vd/F)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple-dose PK measures
\-- Peak concentration at steady state (Cmax,ss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK
\-- Plasma drug concentration at a specified time t steady state (Ct,ss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK method
\-- Average concentration at steady state (Cavg)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK steps
\-- Trough plasma concentration at steady state (Ctrough)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK design
\-- Time to reach peak concentration at steady state (Tmax,ss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK plan
\-- Area under the concentration-time curve within time span t1 to t2 at steady state (AUCt1→t2,ss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK program
\-- AUC in 1 dosing interval (AUCτ) at steady state
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK process
\-- Terminal half-life at steady state (t1/2,ss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK arrangement
\-- Apparent oral clearance at steady state (CL/Fss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK planning
\-- Apparent volume of distribution after oral administration at steady state (Vd/Fss)
Time frame: After collecting blood samples from the last participant, up to 30 days
Assessment of effect duration for IBUMR
\-- For the plasma ibuprofen concentration of IBUMR at steady state, the time to drop to the Ctrough of IBURed-600mg will be calculated.
Time frame: After collecting blood samples from the last participant, up to 30 days
Evaluation of duration of IBUMR effect
\-- Percentage of the test drug-treated subjects with higher or equal plasma ibuprofen concentrations at 12-hour at steady state (C12,ss) compared to the Ctrough of IBURed-600mg will be calculated.
Time frame: After collecting blood samples from the last participant, up to 30 days
Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of AEs and SAEs
Time frame: After collecting blood samples from the last participant, up to 60 days
safety and tolerability
incidence of abnormal Physical examination
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-emergent adverse events
abnormal Vital signs
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of sudden adverse events (safety and tolerability)
abnormal laboratory tests results
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-induced adverse events (safety and tolerability)
abnormal 12-lead ECG exams
Time frame: After collecting blood samples from the last participant, up to 60 days

Study locations

1 site

Taipei Medical University Hospital
Taiwan, China

References and documents

Publications

Albert KS, Gernaat CM. Pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):40-6. doi: 10.1016/s0002-9343(84)80017-0. PubMed 6465162 ↗
Albert KS, Gillespie WR, Wagner JG, Pau A, Lockwood GF. Effects of age on the clinical pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):47-50. doi: 10.1016/s0002-9343(84)80018-2. PubMed 6380280 ↗
Barkin RL, Buvanendran A. Focus on the COX-1 and COX-2 agents: renal events of nonsteroidal and anti-inflammatory drugs-NSAIDs. Am J Ther. 2004 Mar-Apr;11(2):124-9. doi: 10.1097/00045391-200403000-00007. PubMed 14999364 ↗
Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002. PubMed 9515184 ↗
Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770. PubMed 21978149 ↗
Legg T, Paluch E, Jayawardena S. Single- and Multiple-Dose Pharmacokinetics of Immediate-Release/Extended-Release Ibuprofen Tablets. Clin Pharmacol Drug Dev. 2017 Jan;6(1):36-43. doi: 10.1002/cpdd.288. Epub 2016 Sep 22. PubMed 27364900 ↗
Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single- and multiple-dose pharmacokinetics of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) compared with immediate-release hydrocodone bitartrate/ibuprofen and immediate-release tramadol HCl/acetaminophen. J Pain Res. 2015 Sep 30;8:647-56. doi: 10.2147/JPR.S83416. eCollection 2015. PubMed 26508885 ↗
O'Connor TP, Anderson AM, Lennox B, Muldoon C. A novel sustained-release formulation of ibuprofen provides effective once-daily therapy in the treatment of rheumatoid arthritis and osteoarthritis. Br J Clin Pract. 1993 Jan-Feb;47(1):10-3. PubMed 8461240 ↗
Varrassi G, Pergolizzi JV, Dowling P, Paladini A. Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Adv Ther. 2020 Jan;37(1):61-82. doi: 10.1007/s12325-019-01144-9. Epub 2019 Nov 8. PubMed 31705437 ↗
Volans G, Hartley V, McCrea S, Monaghan J. Non-opioid analgesic poisoning. Clin Med (Lond). 2003 Mar-Apr;3(2):119-23. doi: 10.7861/clinmedicine.3-2-119. No abstract available. PubMed 12737366 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2020 to primary completion in Feb 2021, 1 month.

Of 22 industry-sponsored phase 1 interventional studies under Chronic Pain, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 1 month is below that.

Counting every sponsor, half of 50 studies reached it within 24 months; a quarter within 6 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 4, 2021
First posted: Apr 15, 2022
StartActual: Dec 24, 2020
Primary completionActual: Feb 6, 2021
CompletionActual: Jul 18, 2021
Last update: Apr 15, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05329454
Lead sponsor: Overseas Pharmaceuticals, Ltd.
Responsible party: Sponsor
First posted: Apr 15, 2022
Start date: Dec 24, 2020
Primary completion: Feb 6, 2021
Completion: Jul 18, 2021
Last update: Apr 15, 2022

Study contacts

Ming-Che Liu, M.D

principal investigator · Taipei Medical University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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