NCT03785613 is a Phase 1 clinical trial of Test Product T1: Buprenorphine patch (9 mg) in Pain, sponsored by Grünenthal GmbH.

Who is sponsoring NCT03785613?

NCT03785613 is sponsored by Grünenthal GmbH.

What drugs are being tested in NCT03785613?

Interventions in NCT03785613: Test Product T1: Buprenorphine patch (9 mg), Test Product T2: Buprenorphine patch (3.8 mg), Reference Product R: Transtec patch (20 mg), Matching placebo patch to T1, Matching placebo patch to T2, Matching placebo patch to R.

Is NCT03785613 still recruiting?

NCT03785613 is currently completed. Last updated 24 December 2018.

Last reviewed 2018-12-24 · How we verify

NCT03785613

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch

Completed Phase 1 Last updated 24 December 2018

What this trial tests

Phase 1 trial testing Test Product T1: Buprenorphine patch (9 mg) in Pain in 47 participants. Completed in 14 March 2006.

Timeline

7 November 2005

Primary endpoint
14 March 2006

14 March 2006

Quick facts

Lead sponsor	Grünenthal GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	7 November 2005
Primary completion	14 March 2006
Estimated completion	14 March 2006
Sites	1 location across Switzerland

Drugs / interventions tested

Test Product T1: Buprenorphine patch (9 mg) — full drug profile →
Test Product T2: Buprenorphine patch (3.8 mg) — full drug profile →
Reference Product R: Transtec patch (20 mg) — full drug profile →
Matching placebo patch to T1
Matching placebo patch to T2 — full drug profile →
Matching placebo patch to R — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

Adults 18 to 55, male only, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is intended to produce information on the pharmacokinetic characteristics (uptake into and elimination from the body) of two new patch formulations of the analgesic buprenorphine as compared to the reference patch Transtec (Registered Trademark) 35 micrograms per hour (μg/h) in order to assess the suitability of the test formulations for a later confirmatory bioequivalence study. In addition to a reduced buprenorphine load, the new patch formulations may potentially provide improved wearing properties. A placebo patch formulation of the respective test or reference patch will be applied simultaneously to explore the skin tolerability and skin adhesiveness of the patch formulations. Furthermore, the safety and tolerability of the treatments will be assessed.

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:

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Other Grünenthal GmbH trials

Trials by the same sponsor.

NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting
NCT07289776 — A First-in-human Trial of GRT7041 in Healthy Participants · Phase 1 · recruiting
NCT07317063 — A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants · Phase 1 · completed
NCT05449132 — Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the · Phase 3 · completed
NCT05377489 — Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03785613 (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 Grünenthal GmbH
Last refreshed: 24 December 2018

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/NCT03785613.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing