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To evaluate the bioequivalence of Relugolix 120 mg tablets

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male Subjects Under Fasting Conditions - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070477
Enrollment
48
Registered
2024-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Relugolix 120 mg tablets: 120 mg tablet Oral dose Four times Control Intervention1: Orgovyx: 120 mg tablet Oral Dose Four times

Sponsors

BDR Pharmaceuticals Internationals Pvt Ltd
Lead Sponsor
Spinos Life Science and Research Private limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination (including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system) and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel If male and sexually active the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study up to 14 days from the last dose

Exclusion criteria

Exclusion criteria: Evidence of allergy or known hypersensitivity to Relugolix or its inactive ingredients Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Consumption of caffeine and or Xanthine containing products cigarettes and tobacco containing products for at least 48.00 hours prior to check-in

Design outcomes

Primary

MeasureTime frame
To assess the Bioequivalence on Relugolix 120 mg TabletsTimepoint: 22 blood samples 00.00, 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 48.00, and 72.00 hours—

Secondary

MeasureTime frame
To assess the safety and tolerability of Relugolix 120 mg tabletsTimepoint: 22 blood samples 00.00, 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 48.00, and 72.00 hours—

Countries

India

Contacts

Public ContactDr Pradeep T

Spinos Lifescience and Research Private Limited

pradeep.t@spinoslifescience.com8220586899

Outcome results

None listed

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