None listed
Conditions
Interventions
Intervention1: Pilestop Tablet (Diosmin 450
mg + Hesperidin 50 mg film-coated tablet): Name of the drug: Pilestop Tablet (Diosmin 450
mg + Hesperidin 50 mg film-coated tablet),
Route of administratio
Sponsors
The ACME Laboratories 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 18-55 years (both inclusive) of age. 4. Body mass index in the range of 18.5 – 30.0 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. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters: Cmax and AUC0-72Timepoint: From Day 01 to Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters: Tmax, ?z and t1/2Timepoint: From Day 01 to Day 15 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Private limited
Outcome results
None listed