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NCT06199791
Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions
Phase 1 trial testing Lamotrigine 100 MG in Fasting in 24 participants. Completed in 14 June 2023.
9 May 2023
Quick facts
| Lead sponsor | Desitin Arzneimittel GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 3 April 2023 |
| Primary completion | 9 May 2023 |
| Estimated completion | 14 June 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Lamotrigine 100 MG — full drug profile →
Conditions studied
- Fasting — all drugs for Fasting →
Sponsor
Desitin Arzneimittel GmbH — full company profile →
Who can join
Adults 18 to 65, male only, with Fasting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To assess the bioequivalence of lamotrigine from Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg Tablet.
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 NCT06199791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fasting
Currently open trials in the same condition.
- NCT07216989 — Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting · recruiting
- NCT06737224 — The Impact of a 48-hour Fast with or Without Exercise on Immune Cell Metabolism and Glycemic Control in Healthy Active A · NA · recruiting
- NCT06779201 — Fasting Effects on Metabolism and Immunity Study in Human · NA · recruiting
- NCT06420739 — The Semaglutide Study · active not recruiting
- NCT06878781 — Postprandial Metabolome and Metabolic Flexibility · NA · recruiting
Other Desitin Arzneimittel GmbH trials
Trials by the same sponsor.
- NCT07393022 — Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects · Phase 1 · completed
- NCT06214130 — Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets · Phase 1 · completed
- NCT06211283 — Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects. · Phase 1 · completed
- NCT05236842 — Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA) · Phase 2 · 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 NCT06199791 (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 Desitin Arzneimittel GmbH
- Last refreshed: 10 January 2024
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/NCT06199791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing