NCT05729555

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

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Overseas Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pain
• Insomnia

Interventions

Type	Name	Description
DRUG	Compound ibuprofen polyrelease tablets	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®)	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

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study