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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.

An open label, balanced, randomized, two-treatment, two-arm, parallel, single oral dose, bioequivalence study of Apalutamide tablets 60 mg of BDR Pharmaceuticals International Private Limited in comparison with Erleada 60 mg film coated tablets (Apalutamide) of Janssen-Cilag International in healthy, adult, male subjects under fasting condition. - NIl

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048811
Enrollment
36
Registered
2023-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Apalutamide tablets 60 mg: Single oral dose one time only Control Intervention1: Erleada 60 mg film coated tablets (Apalutamide): Single oral dose one time only

Sponsors

BDR Pharmaceuticals Internationals Pvt Ltd
Lead Sponsor

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, 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

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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic analysis Cmax, AUC0-t and AUC0-â?? of drug Timepoint: Day 1 only—

Secondary

MeasureTime frame
1. To monitor the safety and tolerability of the study subjects after administration of Apalutamide tablets 60 mg under fasting condition. 2. Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 1 only—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026