Single‐Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non‐Pregnant, Non‐Lactating Premenopausal Female Subjects Under Fasting Conditions
was 3341.23 ng h/mL for the test product compared to 3365.30 ng h/mL for the reference. Both formulations exhibited comparable safety profiles, with only five mild, resolvable adverse events reported. These findings confirm that the test formulation is bioequivalent to the reference standard, supporting its viability as a safe and effective therapeutic alternative.
Authors
- Amey Mane (ORCID: https://orcid.org/0000-0002-2902-4693)
- Arshad Hussain Khuroo (ORCID: https://orcid.org/0000-0001-5308-4648)
- Chintan Khandhedia (ORCID: https://orcid.org/0009-0004-5632-7181)
- Shruti Dharmadhikari (ORCID: https://orcid.org/0000-0002-2249-2662)
- Reshma Ronald Quadros (ORCID: https://orcid.org/0009-0000-1765-3583)
- Sudershan Kumar
- Gaurav Puppalwar
Institutions
- Sun Pharma (India) (IN)
- Sun Pharma Advanced Research (India) (IN)
Publication Details
- Journal
- Clinical Pharmacology in Drug Development
- Published
- 2026-03-31
- DOI
- https://doi.org/10.1002/cpdd.70053
- Primary Topic
- Endometriosis Research and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.00