None listed
Conditions
Interventions
Intervention1: Esomeprazole 40 mg MUPS tablets: Name of the drug: Esomeprazole 40 mg MUPS tablets, Route of administration: Oral, Frequency: single oral dose, Study duration:09 days
Control Interventi
Sponsors
SunGlow Lifescience Private Ltd
Ms Sunglow Lifescience Private Limited
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 in the range of 18.5 – 30 kg/m2 (both inclusive). 5. Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
Exclusion criteria
Exclusion criteria: 1. Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 2. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs. 3. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 4. History of severe infection or major surgery in the past 6 months. 5. History of Minor surgery or fracture within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-8Timepoint: From Day 01 to Day 09 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, ?z and t1/2Timepoint: From Day 01 to Day 09 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Private limited
Outcome results
None listed