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NCT03639571
Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
Phase 1 trial testing Ibuprofen 200 mg TEPI Medicated Plaster in Healthy in 33 participants. Completed in 25 October 2018.
25 October 2018
Quick facts
| Lead sponsor | Medherant Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 9 August 2018 |
| Primary completion | 25 October 2018 |
| Estimated completion | 25 October 2018 |
| Sites | 1 location across Bulgaria |
Drugs / interventions tested
- Ibuprofen 200 mg TEPI Medicated Plaster — full drug profile →
- Placebo TEPI Plaster
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Medherant Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases: Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.
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 NCT03639571
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ibuprofen 200 mg TEPI Medicated Plaster
Trials testing the same drug.
- NCT03694587 — pK of a Novel 200 mg Ibuprofen Medicated Plaster · Phase 1 · completed
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Other Medherant Ltd trials
Trials by the same sponsor.
- NCT03694587 — pK of a Novel 200 mg Ibuprofen Medicated Plaster · 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 NCT03639571 (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 Medherant Ltd
- Last refreshed: 17 April 2019
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/NCT03639571.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing