NCT03898011 is a Phase 1 clinical trial of Lamotrigine in Healthy Adults, sponsored by Pharmtechnology LLC.

Who is sponsoring NCT03898011?

NCT03898011 is sponsored by Pharmtechnology LLC.

What drugs are being tested in NCT03898011?

Interventions in NCT03898011: Lamotrigine, Lamictal.

What condition does NCT03898011 study?

NCT03898011 studies Healthy Adults.

Is NCT03898011 still recruiting?

NCT03898011 is currently completed. Last updated 6 June 2019.

Last reviewed 2019-06-06 · How we verify

NCT03898011

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

A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

Completed Phase 1 Last updated 6 June 2019

What this trial tests

Phase 1 trial testing Lamotrigine in Healthy Adults in 28 participants. Completed in 4 May 2019.

Timeline

23 March 2019

Primary endpoint
4 May 2019

4 May 2019

Quick facts

Lead sponsor	Pharmtechnology LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	28
Start date	23 March 2019
Primary completion	4 May 2019
Estimated completion	4 May 2019
Sites	1 location across Russia

Drugs / interventions tested

Lamotrigine (lamotrigine) — full drug profile →
Lamictal (lamotrigine) — full drug profile →

Conditions studied

Healthy Adults — all drugs for Healthy Adults →

Sponsor

Pharmtechnology LLC — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Adults. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-labeled, randomized, crossover, two-period, single-center, comparative study, where each participant will be randomly assigned to the reference (Lamictal, 100 mg tablets) or the test (Lamotrigine, 100 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lamotrigine

Trials testing the same drug.

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NCT06729970 — A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects · Phase 1 · completed
NCT06184581 — Lithium Versus Lamotrigine in Bipolar Disorder, Type II · Phase 4 · recruiting
NCT05697614 — The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children · Phase 4 · unknown
NCT05639257 — Treatment of Myotonia - Lamotrigine Versus Namuscla · NA · unknown

Other recruiting trials for Healthy Adults

Currently open trials in the same condition.

NCT07454551 — The Comparison of Different Passive Warm-Up Methods Prior to Exercise · NA · recruiting
NCT07431853 — A Study to Learn About mRNA Vaccines Against Influenza in Adults · Phase 2 · recruiting
NCT07362550 — Effects of 12-Week Balanced Diet on Body Composition & Metabolic Parameters in Twins · NA · recruiting
NCT07284173 — A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Health · Phase 1 · active not recruiting
NCT07518758 — Acute Effect of Polyphenols Supplementation on Endothelial Function and Exercise Related Markers, in Physically Active H · NA · active not recruiting

Other Pharmtechnology LLC trials

Trials by the same sponsor.

NCT06213610 — Bioequivalence Study of Perindopril Tablets in Healthy Volunteers Under Fasting Conditions · Phase 1 · unknown
NCT05940909 — Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under · Phase 1 · unknown
NCT05934799 — Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting · Phase 1 · completed
NCT05685277 — Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under · Phase 1 · completed
NCT05642845 — Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting C · Phase 1 · completed

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 NCT03898011 (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 Pharmtechnology LLC
Last refreshed: 6 June 2019

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/NCT03898011.

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