None listed
Conditions
Interventions
Intervention1: Ibuprofen sodium dihydrate 512 mg tablet: single dose for one day
Control Intervention1: Nurofen Pain Relief Max Strength 512mg Tablets (Ibuprofen sodium dihydrate512 mg): single dose
Sponsors
Lyrus Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2.Willing to be available for the entire study period and to comply with protocol requirements. 3.Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age. 4.Body-mass index of >=18.5 kg/m2 and 5.Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician
Exclusion criteria
Exclusion criteria: 1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs. 2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3.History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months. 5.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 6.Any major illness or hospitalization within 90 days prior to check-in of first period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Cmax, AUC0-t and AUC0-â??Timepoint: From Period-I to Period II for 9 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Period-I to Period II for 9 Days | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed