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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Overseas Pharmaceuticals, Ltd.
• Collaborator: Guangzhou Kangqi Medical Technology Co., LTD
• Treatments: Diphenhydramine; Ibuprofen; Promethazine

Criteria

Inclusion Criteria:

1. 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.

2. Healthy subjects aged 18 years or older (including 18 years old), both male and female.

3. 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).

4. 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.

5. The subject was able to communicate well with the investigator and to understand and comply with the requirements of this study.

Exclusion Criteria:

1. 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.

2. People with active upper gastrointestinal ulcer/bleeding, asthma history, or history of myasthenia gravis, angle-closure glaucoma, and prostatic hypertrophy

3. Patients with poor vascular puncture conditions, or unable to tolerate venipuncture, or a history of blood halo.

4. 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.

5. Patients with abnormal physical examination, vital signs examination, 12-lead electrocardiogram and laboratory examination, and abnormal clinical significance as judged by the study doctor.

6. 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.

7. Women, pregnant, lactating, or women of childbearing age with unprotected sex or positive pregnancy test results within 14 days prior to planned drug administration.

8. , 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;

9. 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.