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NCT05082662
Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet
Phase 1, PHASE2 trial testing Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) in Non-steroidal Anti-inflammatory (NSAID) in 36 participants. Completed in 16 September 2020.
16 September 2020
Quick facts
| Lead sponsor | Humanis Saglık Anonim Sirketi |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 25 August 2020 |
| Primary completion | 16 September 2020 |
| Estimated completion | 16 September 2020 |
| Sites | 1 location across Jordan |
Drugs / interventions tested
- Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) — full drug profile →
- Cataflam® 50 coated tablet — full drug profile →
Conditions studied
- Non-steroidal Anti-inflammatory (NSAID) — all drugs for Non-steroidal Anti-inflammatory (NSAID) →
- Analgesic — all drugs for Analgesic →
- Antipyretic — all drugs for Antipyretic →
Sponsor
Humanis Saglık Anonim Sirketi — full company profile →
Who can join
Adults 18 to 50, any sex, with Non-steroidal Anti-inflammatory (NSAID) or Analgesic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover, bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) versus Cataflam® 50 coated tablet (50 mg Diclofenac Potassium), in healthy subjects under fasting condition
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 NCT05082662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-steroidal Anti-inflammatory (NSAID)
Currently open trials in the same condition.
- NCT07071441 — Indomethacin vs Diclofenac for Preventing PEP · NA · recruiting
Other Humanis Saglık Anonim Sirketi trials
Trials by the same sponsor.
- NCT07372118 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · Phase 1 · completed
- NCT07278349 — Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets · Phase 1 · completed
- NCT07266779 — Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Pr · Phase 1 · completed
- NCT07266766 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · Phase 1 · completed
- NCT07266792 — Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpipraz · 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 NCT05082662 (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 Humanis Saglık Anonim Sirketi
- Last refreshed: 13 December 2023
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/NCT05082662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing