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NCT01956487
Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites
Phase 1 trial testing Propafenone in Arrhythmia, Cardiac in 38 participants. Completed in 27 June 2012.
27 June 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 38 |
| Start date | 11 April 2012 |
| Primary completion | 27 June 2012 |
| Estimated completion | 27 June 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Propafenone — full drug profile →
Conditions studied
- Arrhythmia, Cardiac — all drugs for Arrhythmia, Cardiac →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 55, any sex, with Arrhythmia, Cardiac. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites
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 NCT01956487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Propafenone
Trials testing the same drug.
- NCT05720572 — Antazoline in Comparison to Propafenone in Pharmacological Cardioversion of Atrial Fibrillation. · Phase 4 · unknown
- NCT03674658 — Propafenone in the Treatment of Atrial Fibrillation · NA · completed
- NCT03915340 — Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a S · Phase 1 · completed
Other recruiting trials for Arrhythmia, Cardiac
Currently open trials in the same condition.
- NCT04345627 — Japanese Lead Extraction Registry · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
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 NCT01956487 (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 GlaxoSmithKline
- Last refreshed: 12 June 2017
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/NCT01956487.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing