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NCT01767584
Bioequivalence Study of Cephalexin Tablets 1g
Phase 1 trial testing Cephalexin 1g tablets in Infections, Respiratory Tract in 26 participants. Completed in 14 April 2009.
14 April 2009
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 26 |
| Start date | 6 April 2009 |
| Primary completion | 14 April 2009 |
| Estimated completion | 14 April 2009 |
Drugs / interventions tested
- Cephalexin 1g tablets — full drug profile →
- Cephalexin 1g tablets — full drug profile →
Conditions studied
- Infections, Respiratory Tract — all drugs for Infections, Respiratory Tract →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 40, any sex, with Infections, Respiratory Tract. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent. Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 26 healthy volunteers, both genders, adults between 18-40 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
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 NCT01767584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01767584 (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: 7 July 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/NCT01767584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing