Bioequivalence study of Mini XL 5mg tablet (Prazosin 5 mg ER tablet) of The ACME Laboratories Ltd.

Not Applicable

• Registration Number: CTRI/2023/02/049881
• Lead Sponsor: The ACME Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters Cmax, AUC0-t and AUC0-â?? will be evaluatedTimepoint: From baseline Day 01 to Day 09 for each subjects

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters as Tmax , AUC_%Extrap_obs, λz and t1/2 will be evaluatedTimepoint: From baseline to Day 01 to Day 09