NCT02940561 is a Phase 1 clinical trial of Methotrexate - Amneal in Psoriasis, sponsored by Amneal Pharmaceuticals, LLC.

Who is sponsoring NCT02940561?

NCT02940561 is sponsored by Amneal Pharmaceuticals, LLC.

What drugs are being tested in NCT02940561?

Interventions in NCT02940561: Methotrexate - Amneal, Methotrexate - DAVA.

What condition does NCT02940561 study?

NCT02940561 studies Psoriasis, Rheumatoid Arthritis.

Is NCT02940561 still recruiting?

NCT02940561 is currently status unknown. Last updated 19 October 2016.

Last reviewed 2016-10-19 · How we verify

NCT02940561

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-dose, Two-way, Crossover, Bioequivalence Study of Methotrexate Tablets USP, 2.5 mg Manufactured by Amneal Pharmaceuticals, With Methotrexate Tablets USP 2.5 mg Manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in Patients With Mild to Severe Psoriasis or Rheumatoid Arthritis, Who Are Already on Established Regimens of 2.5 mg Every 12 Hours Under Fasting Condition.

Status unknown Phase 1 Last updated 19 October 2016

What this trial tests

Phase 1 trial testing Methotrexate - Amneal in Psoriasis in 48 participants. Status unknown.

Timeline

1 August 2016

Primary endpoint
1 October 2016

1 October 2016

Quick facts

Lead sponsor	Amneal Pharmaceuticals, LLC
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Enrollment	48
Start date	1 August 2016
Primary completion	1 October 2016
Estimated completion	1 October 2016
Sites	3 locations across India

Drugs / interventions tested

Methotrexate - Amneal — full drug profile →
Methotrexate - DAVA — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Amneal Pharmaceuticals, LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Psoriasis or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Area Under the Curve (AUC0-12)
Time frame: Blood samples will be collected on day 1 of each period, pre-dose and post-dose at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, and 4 hours
The area under the plasma concentration versus time curve, from time 0 to 12 hours post-dose, calculated using linear trapezoidal method. It will be calculated using plasma concentration vs. time profile (Actual time of sample collection) data of the investigational products in individual subjects.
Maximum Plasma Concentration (Cmax)
Time frame: Blood samples will be collected on day 1 of each period, pre-dose and post-dose at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500 and 4 hours
Maximum measured plasma concentration over the time span specified. It will be calculated using plasma concentration vs. time profile (Actual time of sample collection) data of the investigational products in individual subjects.

Sponsor's own description

To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product - Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their bioequivalence.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Other Amneal Pharmaceuticals, LLC trials

Trials by the same sponsor.

NCT06467201 — SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females · Phase 1 · completed
NCT06267274 — A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endp · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02940561 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amneal Pharmaceuticals, LLC
Last refreshed: 19 October 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02940561.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing