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NCT05428293
Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen Oral Suspension
Phase 1 trial testing A1: Ibuprofen/Acetaminophen Fixed dose combination oral suspension (Laboratorios Silanes S.A. de C.V.) in Healthy in 42 participants. Completed in 1 May 2019.
8 March 2019
Quick facts
| Lead sponsor | Laboratorios Silanes S.A. de C.V. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 22 February 2019 |
| Primary completion | 8 March 2019 |
| Estimated completion | 1 May 2019 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- A1: Ibuprofen/Acetaminophen Fixed dose combination oral suspension (Laboratorios Silanes S.A. de C.V.)
- A2: Ibuprofen (Advil®, Pfizer S.A. de C.V.) — full drug profile →
- A3: Acetaminophen (Tylenol®, from Janssen-Cilag, S.A. de C.V.) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Laboratorios Silanes S.A. de C.V. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study was carried out in the Clinical and Analytical Unit of the Pharmacology and Toxicology Department of the Faculty of Medicine of the Autonomous University of Nuevo León, in order to compare the bioavailability (Cmax, AUC) of an oral formulation containing Ibuprofen 100 mg/Acetaminophen 125 mg in combination with the two oral formulations Ibuprofen 100 mg or Acetaminophen 125 mg administered as a single dose, in healthy subjects under fasting conditions.
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 NCT05428293
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Laboratorios Silanes S.A. de C.V. trials
Trials by the same sponsor.
- NCT07328022 — Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Synovitis · Phase 3 · completed
- NCT06863701 — Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis · Phase 3 · recruiting
- NCT07444164 — Comparative Bioavailability Study Between Ticagrelor and ASA Administered Individually or in Combination. · Phase 1 · completed
- NCT06916884 — Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Deslor · Phase 3 · recruiting
- NCT06863662 — Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05428293 (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 Laboratorios Silanes S.A. de C.V.
- Last refreshed: 28 June 2022
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/NCT05428293.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing