To study the bioequivalence of Relugolix 120 mg tablets

Recruitment & Eligibility

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

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

Primary Outcome Measures

Name	Time	Method
To assess the Bioequivalence on Relugolix 120 mg TabletsTimepoint: 22 blood samples <br/ ><br>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 Outcome Measures

Name	Time	Method
<br/ ><br>Outcome TimePoints <br/ ><br>To assess the safety and tolerability of Relugolix 120 mg tabletsTimepoint: 22 blood samples <br/ ><br>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