Bioequivalence study of Apalutamide tablets 60 mg in comparison with Erleada 60 mg film coated tablets (Apalutamide) of Janssen-Cilag International in healthy, adult, male subjects under fasting condition.

Not Applicable

Completed

• Registration Number: CTRI/2023/01/048811
• Lead Sponsor: BDR Pharmaceuticals Internationals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-29
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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, male subject of 18-55 years of age.

4.Body mass index in the range of 18 â?? 30 kg/m2.

5.Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician

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.

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.

Study & Design

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