Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729555
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-02-06
Brief Title:
Comparative Pharmacokinetic PK Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under Fasting Condition
Sponsor:
Overseas Pharmaceuticals Ltd
Organization:
Overseas Pharmaceuticals Ltd
Study Overview
Official Title:
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 400mg50mg of Overseas Pharmaceuticals Ltd With Motrin IB Ibuprofen Tablets USP 200mg 2 200mg and BENADRYL Diphenhydramine Hydrochloride Tablet 25 mg225 mg Distributed by - Johnson Johnson Consumer Inc McNeil Consumer Healthcare Division in Normal Healthy Adult Human Subjects Under Fasting Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 LtdSpecification 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
Main objective Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets developed by Overseas Pharmaceuticals LtdSpecification 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 11 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 10 h before administration and 5 min 15 min 30 min 45 min 10 h 125 h 15 h 20 h 25 h 30 h 35 h 40 h 45 h 50 h 55 h 60 h 70 h 80 h 90 h 100 h 120 h 240 h 360 h and 480 h Upper limb venous blood was collected at 25 time points About 10 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 10 h before administration and 20 05 h 80 05 h 240 10 h 480 10 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
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 10 h before administration and 5 min 15 min 30 min 45 min 10 h 125 h 15 h 20 h 25 h 30 h 35 h 40 h 45 h 50 h 55 h 60 h 70 h 80 h 90 h 100 h 120 h 240 h 360 h and 480 h Upper limb venous blood was collected at 25 time points About 10 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 10 h before administration and 20 05 h 80 05 h 240 10 h 480 10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None