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Also known as GR37547 tablet
GR37547 · 1 trial · 1 indication
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Treatment sequence: A/B | EXPERIMENTAL | Eligible subjects will be randomized to receive a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) administered orally on Day 1 in each treatment period. The washout period will be of at least 7 days and not more than 14 days. |
| Treatment sequence: B/A | EXPERIMENTAL | Eligible subjects will be randomized to receive a single dose of Treatment B (ciprofloxacin 500 mg reference tablet) followed by Treatment A (GR37547 500 mg tablet) administered orally. The washout period will be of at least 7 days and not more than 14 days. |
| Name | Type | Description |
|---|---|---|
| GR37547 tablet | DRUG | A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed "GSK500"on lower side. |
| Ciprofloxacin reference tablet | DRUG | A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water. Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500" marked on upper side and "BAYER" on lower side. |
Inclusion Criteria: * Subject must be between 18 and 60 years of age inclusive, at the time of signing the informed consent. * Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, labora...
GR37547 is an investigational small molecule antibacterial being developed by GSK plc for bacterial infections. It has been studied as a 500 mg tablet in a Phase 1 bioequivalence trial in healthy adult volunteers. It is not an approved medicine and remains in clinical development.
GR37547 is being developed for bacterial infections. Its only recorded clinical study enrolled healthy adult volunteers rather than patients, so the program is at an early stage and no approved use exists. GSK plc is the developer.
GR37547 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 bioequivalence study of the 500 mg tablet conducted in South Africa.
GR37547 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not advanced beyond early clinical testing, and the drug is investigational rather than approved.
GR37547 has been studied in one completed Phase 1 trial, NCT03150082, titled a bioequivalence study between GR37547 500 mg tablet and ciprofloxacin 500 mg tablet reference product in healthy adult subjects. It enrolled 26 participants in South Africa and used a controlled, randomized design.
Yes. GR37547 tablet is simply the tablet formulation of GR37547, the 500 mg oral tablet evaluated in the Phase 1 bioequivalence study. Both names refer to the same investigational GSK plc antibacterial candidate.