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NCT01767571
Bioequivalence Study of Cephalexin Suspension 250
Phase 1 trial testing Cephalexin 125 mg/5ml in Infections, Respiratory Tract in 28 participants. Completed in 8 February 2011.
8 February 2011
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 28 |
| Start date | 30 January 2011 |
| Primary completion | 8 February 2011 |
| Estimated completion | 8 February 2011 |
Drugs / interventions tested
- Cephalexin 125 mg/5ml — full drug profile →
- Cephalexin 250mg/5ml — 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 50, 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 suspension are bioequivalent. Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for Ceporex and 20 ml of suspension for Keflex® . 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 28 healthy volunteers, both genders, adults between 18-50 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 NCT01767571
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Related trials
Other trials of Cephalexin 125 mg/5ml
Trials testing the same drug.
- NCT01767532 — Bioequivalence Study of Cephalexin Suspension 125 · Phase 1 · completed
Other GlaxoSmithKline trials
Trials by the same sponsor.
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- 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 NCT01767571 (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: 5 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/NCT01767571.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing