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NCT04623814
the Safety, Tolerability, and Pharmacokinetics Study of HEC113995
Phase 1 trial testing Food in Major Depressive Disorder in 58 participants. Completed in 12 August 2020.
12 August 2020
Quick facts
| Lead sponsor | Sunshine Lake Pharma Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 30 March 2020 |
| Primary completion | 12 August 2020 |
| Estimated completion | 12 August 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Food
- HEC113995 — full drug profile →
- placebo
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Sunshine Lake Pharma Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects
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 NCT04623814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Food
Trials testing the same drug.
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- NCT06378658 — A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Heal · Phase 1 · completed
- NCT06333184 — Smoothies and Blood Sugars · NA · completed
- NCT05521711 — TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation · NA · recruiting
- NCT05870891 — Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults · NA · completed
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
- NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
- NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
- NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
- NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other Sunshine Lake Pharma Co., Ltd. trials
Trials by the same sponsor.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT05048368 — Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function · Phase 1 · not yet recruiting
- NCT07376200 — Single-ascending Dose Study of HEC-151 Injection · Phase 1 · not yet recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07211165 — Clinical Study on the Mass Balance of Clifutinib · 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 NCT04623814 (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 Sunshine Lake Pharma Co., Ltd.
- Last refreshed: 25 November 2020
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/NCT04623814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing