Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under Fasting Condition

NCT05729555 | Unknown Phase 1 FDA Drug

• 1 other identifier: YYKQ-202210
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Insomnia

Keywords

Ibuprofen; Diphenhydramine Hydrochloride

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 month

Secondary Outcomes (4)

• Peak concentration of the first dosing (Cmax)

  1 month

• Time to reach peak concentration of the first dosing (Tmax)

  1 month

• Terminal half-life (T1/2)

  1 month

• Mean residence time (MRT)

  1 month

Study Arms (2)

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

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

Drug: Compound ibuprofen polyrelease tablets

Interventions

Compound ibuprofen polyrelease tablets DRUG

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

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

Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• Guangzhou Kangqi Medical Technology Co., LTD: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Dr. Huaihan Cai, Director of Medical Affairs

CONTACT

0086-18352616957; caihuaihan@overseaspharm.com

Zhujiang Hospital of Southern Medical University zjyygcp@163.com, Clinical Trial center

CONTACT

020-62783372; wuyuzgp@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: April 3, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)