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

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.

Timeline

Start

2023-04-03

Primary completion

2023-10-31

Completion

2023-12-31

Drugs

Indications