PainPhase 1NCT05729555
Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under Fasting Condition
A Phase 1 study testing Compound ibuprofen polyrelease tablets and reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®) in people with Pain and Insomnia, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets were randomized, open, two-cycle Comparative pharmacokinetic test under double crossover and fasting condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Compound ibuprofen polyrelease tablets and reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2023to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject was fully informed of the trial purpose, nature, methods, and possible adverse effects, voluntarily acted as the subject, and signed the informed consent form prior to the start of any study procedures.
- Healthy subjects aged 18 years or older (including 18 years old), both male and female.
- Male weight was 50.0 kg and female weight 45.0 kg; body mass index (BMI) was within the range of 19.0 to 26.0 kg/m2 (including the cut-off value).
- There is no birth plan and voluntary appropriate and effective contraceptive measures between the signing of the informed consent form and within 6 months after the end of the study, and no sperm donation and egg donation plan.
- The subject was able to communicate well with the investigator and to understand and comply with the requirements of this study.
Who cannot join
- Allergic constitution or a history of clinically significant food, drug allergy, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or allergic to any component of ibuprofen or diphenhydramine; or a history of asthma or other allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs; or allergic to ethanolamine drugs.
- People with active upper gastrointestinal ulcer/bleeding, asthma history, or history of myasthenia gravis, angle-closure glaucoma, and prostatic hypertrophy
- Patients with poor vascular puncture conditions, or unable to tolerate venipuncture, or a history of blood halo.
- There are clinically meaningful diseases of cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, divine, menstrual, mental, mental, immune, skin and metabolic disorders, which are considered meaningful by the investigator, or a chronic or serious medical history of these diseases; or a surgical history that may affect the absorption and metabolism of drugs.
- Patients with abnormal physical examination, vital signs examination, 12-lead electrocardiogram and laboratory examination, and abnormal clinical significance as judged by the study doctor.
- human immunodeficiency virus (HIV) antibody, or hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or treponema pallidum antibody (anti-TP) test results are positive.
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- Women, pregnant, lactating, or women of childbearing age with unprotected sex or positive pregnancy test results within 14 days prior to planned drug administration.
- , those who were vaccinated within 3 months before the screening (except COVID-19 vaccine), or who received COVID-19 vaccine within 1 week before the screening or who planned to receive any vaccine during the trial or 1 week after the end of the study;
- or who donated 400 mL or received blood products or intended to donate blood (including blood components) during the trial or within 3 months after the end of the trial.
Trial locations and contacts
1 site in 1 country.
Zhujiang Hospital of Southern Medical University zjyygcp@163.com, Clinical Trial center contact
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510260
he shuai, Doctoral students, 18925092493, hs43555@163.com
About this study
Official title: An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Oral Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets, 400mg/50mg of Overseas Pharmaceuticals, Ltd. With Motrin IB (Ibuprofen Tablets USP 200mg (2× 200mg)) and BENADRYL (Diphenhydramine Hydrochloride Tablet 25 mg(2×25 mg)), Distributed by - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division in Normal Healthy, Adult, Human Subjects Under Fasting Condition.
Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets were randomized, open, two-cycle Comparative pharmacokinetic test under double crossover and fasting condition.
Main objective: Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets developed by Overseas Pharmaceuticals, Ltd.(Specification: each tablet containing ibuprofen 400 mg, Phenhenhydramine hydrochloride 50 mg) is the test preparation, JOHNSON \& JOHNSON CONSUMER INC. Production (trade name: Motrin IB®, Specification: 200 mg) for comparative drug product 1, JOHNSON \& JOHNSON CONSUMER INC. Hydrodramine hydrochloride (trade name: Benadryl®, Specification: 25 mg) for comparative formulation 2, In the fasting state, To investigate the pharmacokinetic parameters in healthy Chinese subjects of 1 and 2, And were compared. Secondary objective: To evaluate the safety of a single oral administration of Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets and reference 1 and reference 2 diphenhydramine hydrochloride tablets in fasting conditions in healthy Chinese subjects.
Read the detailed description
Subjects were randomized in a 1:1 ratio to one of 2 T-R (R-T). That is, 8 subjects in the first cycle T group had fasting 1 tablet of test preparation (compound ibuprofen polyrelease tablet, specification: each containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg, Overseas Pharmaceuticals, Ltd.; 8 subjects in the R group had fasting 1 ibuprofen tablet (200 mg) and 2 tablets of diphenhydramine hydrochloride (25 mg) with 240 ml warm water. Cross-administration after 7 days.
The 16 healthy subjects (including male and female subjects) were randomly divided into 2 groups, T-R and R-T, with 8 participants each. The selected subjects were admitted to the phase I ward of the clinical research center 1 day before each cycle and fasted for more than 10h before each cycle.
At 0 h (within 1.0 h before administration) and 5 min, 15 min, 30 min, 45 min, 1.0 h, 1.25 h, 1.5 h, 2.0 h, 2.5 h, 3.0 h, 3.5 h, 4.0 h, 4.5 h, 5.0 h, 5.5 h, 6.0 h, 7.0 h, 8.0 h, 9.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, and 48.0 h, Upper limb venous blood was collected at 25 time points, About 1.0 mL blood was discarded before each blood samples using intravenous indwelling needle, After each blood collection, About 4 mL of blood was collected into vacuum labeled EDTA-K2 anticoagulant.
The seated vital signs (including temperature, pulse, and blood pressure) were measured at 0 h before administration (within 1.0 h before administration) and 2.0 ± 0.5 h, 8.0 ± 0.5 h, 24.0 ± 1.0 h, 48.0 ± 1.0 h after administration. The subjects had a physical examination, vital signs, electrocardiogram and laboratory tests after the blood sampling. Medical staff during the study to observe and ask the subjects about subjective feelings and possible adverse events during the trial. If a subject has an AE during the study, the investigator should follow up the AE as far as possible until the adverse event response, or return to the screening period level, or the subject has stable condition.
- Being tested
- Compound ibuprofen polyrelease tablets, reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)
- Keywords
- Ibuprofen, Diphenhydramine Hydrochloride
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound ibuprofen polyrelease tabletsDrug
Specification: Each tablet containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg Batch number: 22082801 Content: Ibuprofen 96.9%, diphenhydramine hydrochloride 102.4% Effective: August 27,2024 S torage conditions: sealed, room temperature. Manufacturers: Overseas Pharmaceuticals, Ltd. Usage and dosage：Once a day, one tablet at a time
reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)Drug
Specification: 200 mg Batch number: 2CE2330 Content: 100.5% Expiry date: December 2023 Storage conditions; Storage in 20℃ -25℃ manufacturer: JOHNSON \& JOHNSON CONSUMER INC. Usage and dosage：Once a day, two tablets at a time
Specification: 25 mg Batch number: BCC009 Content: 99.2% Effective to: December 2023 storage conditions; storage at 20℃ -25℃, shading manufacturer: JOHNSON \& JOHNSON CONSUMER INC Usage and dosage：Once a day, two tablets at a time
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets | Experimental | Specification: Each tablet containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg Batch number: 22082801 Content: Ibuprofen 96.9%, diphenhydramine hydrochloride 102.4% Effective: August 27,2024 S torage conditions: sealed, room temperature. Manufacturers: Overseas Pharmaceuticals, Ltd. Usage and dosage：Once a day, one tablet at a time Receives: Drug: reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®) |
| Motrin® IB (ibuprofen tablets USP) 200mg and BENADRYL® (diphenhydramine hydrochloride tablet) 25 mg | Active comparator | Specification: 200 mg Batch number: 2CE2330 Content: 100.5% Expiry date: December 2023 Storage conditions; Storage in 20℃ -25℃
Specification: 25 mg Batch number: BCC009 Content: 99.2% Effective to: December 2023 storage conditions; storage at 20℃ -25℃, shading
Distributed by: Johnson \& Johnson Consumer Inc., McNeil Consumer Healthcare Division Usage and dosage：Once a day, two tablets at a time Receives: Drug: Compound ibuprofen polyrelease tablets |
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 (4)
Peak concentration of the first dosing (Cmax)
Individual felodipine 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 felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Terminal half-life (T1/2)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Mean residence time (MRT)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start3 Apr 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- Test Product (T)：Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets, 400mg/50mg of Overseas Pharmaceuticals, Ltd. Reference Product (R)：Motrin® IB (ibuprofen tablets USP) 200mg and BENADRYL® (diphenhydramine hydrochloride tablet) 25 mg Distributed by: Johnson \& Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Kangqi Medical Technology Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729555
- Sponsor's protocol ID
- YYKQ-202210
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Oral Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets, 400mg/50mg of Overseas Pharmaceuticals, Ltd. With Motrin IB (Ibuprofen Tablets USP 200mg (2× 200mg)) and BENADRYL (Diphenhydramine Hydrochloride Tablet 25 mg(2×25 mg)), Distributed by - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division in Normal Healthy, Adult, Human Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT05729555
- Acronym / sponsor ID
- YYKQ-202210
- Keywords
- Ibuprofen, Diphenhydramine Hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Kangqi Medical Technology Co., LTD
- Study start
- 3 Apr 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2023 (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.
Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets were randomized, open, two-cycle Comparative pharmacokinetic test under double crossover and fasting condition.
Main objective: Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets developed by Overseas Pharmaceuticals, Ltd.(Specification: each tablet containing ibuprofen 400 mg, Phenhenhydramine hydrochloride 50 mg) is the test preparation, JOHNSON \& JOHNSON CONSUMER INC. Production (trade name: Motrin IB®, Specification: 200 mg) for comparative drug product 1, JOHNSON \& JOHNSON CONSUMER INC. Hydrodramine hydrochloride (trade name: Benadryl®, Specification: 25 mg) for comparative formulation 2, In the fasting state, To investigate the pharmacokinetic parameters in healthy Chinese subjects of 1 and 2, And were compared. Secondary objective: To evaluate the safety of a single oral administration of Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets and reference 1 and reference 2 diphenhydramine hydrochloride tablets in fasting conditions in healthy Chinese subjects.
Detailed description
Subjects were randomized in a 1:1 ratio to one of 2 T-R (R-T). That is, 8 subjects in the first cycle T group had fasting 1 tablet of test preparation (compound ibuprofen polyrelease tablet, specification: each containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg, Overseas Pharmaceuticals, Ltd.; 8 subjects in the R group had fasting 1 ibuprofen tablet (200 mg) and 2 tablets of diphenhydramine hydrochloride (25 mg) with 240 ml warm water. Cross-administration after 7 days.
The 16 healthy subjects (including male and female subjects) were randomly divided into 2 groups, T-R and R-T, with 8 participants each. The selected subjects were admitted to the phase I ward of the clinical research center 1 day before each cycle and fasted for more than 10h before each cycle.
At 0 h (within 1.0 h before administration) and 5 min, 15 min, 30 min, 45 min, 1.0 h, 1.25 h, 1.5 h, 2.0 h, 2.5 h, 3.0 h, 3.5 h, 4.0 h, 4.5 h, 5.0 h, 5.5 h, 6.0 h, 7.0 h, 8.0 h, 9.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, and 48.0 h, Upper limb venous blood was collected at 25 time points, About 1.0 mL blood was discarded before each blood samples using intravenous indwelling needle, After each blood collection, About 4 mL of blood was collected into vacuum labeled EDTA-K2 anticoagulant.
The seated vital signs (including temperature, pulse, and blood pressure) were measured at 0 h before administration (within 1.0 h before administration) and 2.0 ± 0.5 h, 8.0 ± 0.5 h, 24.0 ± 1.0 h, 48.0 ± 1.0 h after administration. The subjects had a physical examination, vital signs, electrocardiogram and laboratory tests after the blood sampling. Medical staff during the study to observe and ask the subjects about subjective feelings and possible adverse events during the trial. If a subject has an AE during the study, the investigator should follow up the AE as far as possible until the adverse event response, or return to the screening period level, or the subject has stable condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test Product (T)：Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets, 400mg/50mg of Overseas Pharmaceuticals, Ltd. Reference Product (R)：Motrin® IB (ibuprofen tablets USP) 200mg and BENADRYL® (diphenhydramine hydrochloride tablet) 25 mg Distributed by: Johnson \& Johnson Consumer Inc., McNeil Consumer Healthcare Division
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets | Experimental | Drug: reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)Specification: Each tablet containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg Batch number: 22082801 Content: Ibuprofen 96.9%, diphenhydramine hydrochloride 102.4% Effective: August 27,2024 S torage conditions: sealed, room temperature. Manufacturers: Overseas Pharmaceuticals, Ltd. Usage and dosage：Once a day, one tablet at a time |
| Motrin® IB (ibuprofen tablets USP) 200mg and BENADRYL® (diphenhydramine hydrochloride tablet) 25 mg | Active comparator | Drug: Compound ibuprofen polyrelease tabletsSpecification: 200 mg Batch number: 2CE2330 Content: 100.5% Expiry date: December 2023 Storage conditions; Storage in 20℃ -25℃ Specification: 25 mg Batch number: BCC009 Content: 99.2% Effective to: December 2023 storage conditions; storage at 20℃ -25℃, shading Distributed by: Johnson \& Johnson Consumer Inc., McNeil Consumer Healthcare Division Usage and dosage：Once a day, two tablets at a time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject was fully informed of the trial purpose, nature, methods, and possible adverse effects, voluntarily acted as the subject, and signed the informed consent form prior to the start of any study procedures.
- Healthy subjects aged 18 years or older (including 18 years old), both male and female.
- Male weight was 50.0 kg and female weight 45.0 kg; body mass index (BMI) was within the range of 19.0 to 26.0 kg/m2 (including the cut-off value).
- There is no birth plan and voluntary appropriate and effective contraceptive measures between the signing of the informed consent form and within 6 months after the end of the study, and no sperm donation and egg donation plan.
- The subject was able to communicate well with the investigator and to understand and comply with the requirements of this study.
Key exclusion criteria (9 listed)
- Allergic constitution or a history of clinically significant food, drug allergy, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or allergic to any component of ibuprofen or diphenhydramine; or a history of asthma or other allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs; or allergic to ethanolamine drugs.
- People with active upper gastrointestinal ulcer/bleeding, asthma history, or history of myasthenia gravis, angle-closure glaucoma, and prostatic hypertrophy
- Patients with poor vascular puncture conditions, or unable to tolerate venipuncture, or a history of blood halo.
- There are clinically meaningful diseases of cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, divine, menstrual, mental, mental, immune, skin and metabolic disorders, which are considered meaningful by the investigator, or a chronic or serious medical history of these diseases; or a surgical history that may affect the absorption and metabolism of drugs.
- Patients with abnormal physical examination, vital signs examination, 12-lead electrocardiogram and laboratory examination, and abnormal clinical significance as judged by the study doctor.
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 |
|---|---|---|
| Compound ibuprofen polyrelease tabletsSpecification: Each tablet containing ibuprofen 400 mg, diphenhydramine hydrochloride 50 mg Batch number: 22082801 Content: Ibuprofen 96.9%, diphenhydramine hydrochloride 102.4% Effective: August 27,2024 S torage conditions: sealed, room temperature. Manufacturers: Overseas Pharmaceuticals, Ltd. Usage and dosage：Once a day, one tablet at a time | Drug | Motrin® IB (ibuprofen tablets USP) 200mg and BENADRYL® (diphenhydramine hydrochloride tablet) 25 mg |
| reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)Specification: 200 mg Batch number: 2CE2330 Content: 100.5% Expiry date: December 2023 Storage conditions; Storage in 20℃ -25℃ manufacturer: JOHNSON \& JOHNSON CONSUMER INC. Usage and dosage：Once a day, two tablets at a time Specification: 25 mg Batch number: BCC009 Content: 99.2% Effective to: December 2023 storage conditions; storage at 20℃ -25℃, shading manufacturer: JOHNSON \& JOHNSON CONSUMER INC Usage and dosage：Once a day, two tablets at a time | Drug | Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets |
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.
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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.
Zhujiang Hospital of Southern Medical University zjyygcp@163.com, Clinical Trial center contact
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 Compound ibuprofen polyrelease tablets and reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®) in people with Pain and Insomnia, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Huaihan Cai, Director of Medical Affairs (0086-18352616957, caihuaihan@overseaspharm.com), or a site near the patient. 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?
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 15 Feb 2023.