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

PHASE1UnknownINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 3, 2023

Primary Completion Date

October 31, 2023

Study Completion Date

December 31, 2023

Conditions
PainInsomnia
Interventions
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"

Trial Locations (1)

510260

Zhujiang Hospital of Southern Medical University, Guangzhou

Sponsors
All Listed Sponsors
collaborator

Guangzhou Kangqi Medical Technology Co., LTD

UNKNOWN

lead

Overseas Pharmaceuticals, Ltd.

INDUSTRY

NCT05729555 - Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under Fasting Condition | Biotech Hunter | Biotech Hunter