Last reviewed · How we verify
NCT00939458
Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions
Phase 1 trial testing Lamotrigine in Healthy. Completed.
Quick facts
| Lead sponsor | Torrent Pharmaceuticals Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Sites | 1 location across India |
Drugs / interventions tested
- Lamotrigine (lamotrigine) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Torrent Pharmaceuticals Limited — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* Objective: * To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions. * Study Design: * A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.
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:
- PubMed search for NCT00939458
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lamotrigine
Trials testing the same drug.
- NCT06929273 — A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) · Phase 3 · recruiting
- 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
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Torrent Pharmaceuticals Limited trials
Trials by the same sponsor.
- NCT04015375 — Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris · Phase 3 · completed
- NCT00939367 — Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions · Phase 1 · completed
- NCT01218022 — Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versu · Phase 1 · completed
- NCT01218698 — Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versu · Phase 1 · completed
- NCT01218711 — Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Ph · 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)
- Trial protocol + status: ClinicalTrials.gov NCT00939458 (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 Torrent Pharmaceuticals Limited
- Last refreshed: 25 October 2017
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/NCT00939458.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing