drugset / Trial / NCT03418805
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers
Phase 1
Terminated
31 enrolled
Overseas Pharmaceuticals, Ltd.
Virginia Contract Research Organization Co., Ltd. · collab
RandomizedCrossoverOpen-labelBasic science
Summary
To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers.
Timeline
- Start
- 2017-12-11
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 200 mg | — |
| Subject | Ibuprofen | Small molecule | 600 mg | Oral |
Indications
No indication recorded.