A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 220 participants (planned 200)
    • Primary completion date changed from estimate of Jan 5, 2026 to Jun 19, 2026
    • Interventions: CBD Broad Extract (50 mg/0.5 ml) (Dietary Supplement), CBD Isolate (25 mg/0.5 ml) (Dietary Supplement), CBD Isolate (40 mg/0.5 ml) (Dietary… to CBD Broad Extract (50 mg/0.5 ml) (Dietary Supplement), CBD Isolate (25 mg/0.5 ml) (Dietary Supplement), CBD Isolate (40 mg/0.5 ml) (Dietary…
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 15 of 18 entries
    • Site details revised at 6 of 6 sites
  2. Primary completion date: Oct 5, 2025 to Jan 5, 2026
    • Study completion date: Oct 5, 2025 to Feb 5, 2026
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 5, 2024 to Feb 20, 2025
    • Study sites: 7 to 6
    v3
  4. Secondary endpoints: 17 to 18v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.
Trial Details
NCT Number NCT06473246
Lead Sponsor Vedic Lifesciences Pvt. Ltd.
Conditions
(from sponsor)		 Healthy Population
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov