None listed
Conditions
Interventions
Intervention1: Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg: single oral dose, one time only
Control Intervention1: Tramacet® 37.5 mg/325 mg effervescent tablet: single oral dose, one time
Sponsors
SciTech Specialities Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age. 4.Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive). 5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
Exclusion criteria
Exclusion criteria: 1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening. 2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 5.History of severe infection or major surgery in the past 6 months. 6.History of Minor surgery or fracture within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-â??Timepoint: Day 1 to day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 1 to day 3 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed