deltatrials
Completed PHASE1 NCT03972462

NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions

Sponsor: Nobelpharma

Conditions Bioavailability Study
Interventions NPC-12G Gel 0.2% Rapamune® 2 mg tablet
Updated 5 times since 2019 Last updated: Mar 4, 2020 Started: May 31, 2019 Primary completion: Jun 17, 2019 Completion: Jun 17, 2019

This PHASE1 trial investigates Bioavailability Study and is currently completed. Nobelpharma leads this study, which shows 5 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Apr 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Jul 2019 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

    First recorded

May 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Nobelpharma
Data source: Nobelpharma

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Miami, United States