Evidence map›Paper›PMID 41916909›Full record

Trial reportClinical pharmacology in drug development2026

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.

Sudershan Kumar, Arshad Khuroo, Reshma Quadros, Shruti Dharmadhikari, Chintan Khandhedia, Gaurav Puppalwar, Amey Mane

Abstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Sudershan KumarSun Pharmaceutical Industries Limited, Mumbai, India.
Arshad KhurooSun Pharmaceutical Industries Limited, Mumbai, India.
Reshma QuadrosSun Pharmaceutical Industries Limited, Mumbai, India.
Shruti DharmadhikariSun Pharma Laboratories Limited, Mumbai, India.
Chintan KhandhediaSun Pharma Laboratories Limited, Mumbai, India.
Gaurav PuppalwarSun Pharma Laboratories Limited, Mumbai, India.
Amey ManeSun Pharma Laboratories Limited, Mumbai, India.

Funding

Sun Pharma Laboratories
6 · The paper itself

Abstract

Elagolix is a short-acting oral gonadotropin-releasing hormone antagonist utilized for treating endometriosis-associated pain by rapidly suppressing gonadotropins and estradiol. Although well characterized in Western populations, clinical data regarding its use in Indian women remain limited. This study evaluated the pharmacokinetics, safety, and bioequivalence of a test 200 mg Elagolix tablet against a reference formulation under fasting conditions. The randomized, open-label, four-period crossover trial involved 60 healthy women aged 18-40 years who received single oral doses of either formulation. Plasma concentrations were monitored via validated UHPLC-MS/MS for 24 h post-dose. Fifty-nine participants completed the study, with results indicating rapid absorption (median T

Indexed as

Hydrocarbons, FluorinatedPyrimidinesAdministration, OralAdolescentAdultArea Under CurveCross-Over StudiesFastingFemaleHalf-LifeHealthy VolunteersHumansPremenopauseTabletsTandem Mass SpectrometryTherapeutic EquivalencyelagolixHydrocarbons, FluorinatedPyrimidinesTabletsbioequivalenceelagolixendometriosispharmacokineticssafety

Identifiers

PMID41916909
PMCPMC13038420

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.