None listed
Conditions
Interventions
Intervention1: Mini XL 5mg tablet (Prazosin 5 mg ER tablet): Dose: single oral dose,
Frequency: single dose for period I or period II,
Route of administration: oral,
Duration of the study: 09 days.
Co
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 18-45 years (both inclusive) of age. 4. Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Cmax, AUC0-t and AUC0-â?? will be evaluatedTimepoint: From baseline Day 01 to Day 09 for each subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters as Tmax , AUC_%Extrap_obs, λz and t1/2 will be evaluatedTimepoint: From baseline to Day 01 to Day 09 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed