NCT01859377 is a Phase 1 clinical trial of V0498 - A mg in Healthy Volunteers, sponsored by Pierre Fabre Medicament.

Who is sponsoring NCT01859377?

NCT01859377 is sponsored by Pierre Fabre Medicament.

What drugs are being tested in NCT01859377?

Interventions in NCT01859377: V0498 - A mg, Ibuprofen.

What condition does NCT01859377 study?

NCT01859377 studies Healthy Volunteers.

Is NCT01859377 still recruiting?

NCT01859377 is currently completed. Last updated 21 June 2013.

Last reviewed 2013-06-21 · How we verify

NCT01859377

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

Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

Completed Phase 1 Last updated 21 June 2013

What this trial tests

Phase 1 trial testing V0498 - A mg in Healthy Volunteers in 26 participants. Completed in 1 June 2013.

Timeline

1 May 2013

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 May 2013
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across Belgium

Drugs / interventions tested

V0498 - A mg — full drug profile →
Ibuprofen (ibuprofen) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Pierre Fabre Medicament — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum Plasma Concentration (Cmax)
Time frame: 11 time points up to 10h after administration
Time of Maximum Concentration
Time frame: 11 time points up to 10h after administration
Area Under Curve (AUC0-72)
Time frame: 11 time points up to 10h after administration

Sponsor's own description

The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.

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:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Pierre Fabre Medicament trials

Trials by the same sponsor.

NCT06690489 — An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients · completed
NCT06669117 — FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations · Phase 1, PHASE2 · recruiting
NCT06688370 — The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study · terminated
NCT06043817 — First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer H · Phase 1, PHASE2 · recruiting
NCT07096206 — Characteristics and Impacts of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) in Boys: An Observational Internationa · active not recruiting

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 NCT01859377 (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 Pierre Fabre Medicament
Last refreshed: 21 June 2013

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/NCT01859377.

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