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Clinical trial

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.

NCT05729555 is registered in ClinicalTrials.gov with Overseas Pharmaceuticals, Ltd. as lead sponsor.

NCT NCT05729555
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Registry record

As filed in ClinicalTrials.gov.

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, 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.
Lead sponsor
Overseas Pharmaceuticals, Ltd.
Phase
Phase 1
Overall status
Unknown status
Start date
April 3, 2023
Completion date
December 31, 2023
Enrollment
16 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

insomnia, pain