Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Griseofulvin · 1 trial · 1 indication
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized Cmax (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for Cmax to assess bioequivalence.
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-t) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-t) to assess bioequivalence.
Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-inf) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-inf) to assess bioequivalence.
Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) AUC(0-t) was used during calculation of dose proportionality.
Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) Cmax was used during calculation of dose proportionality.
| Arm | Type | Description |
|---|---|---|
| Participants receiving T1T2R | EXPERIMENTAL | Participants will receive a single oral dose of Griseofulvin T1: 1 x 500 mg Tablet once in Period 1 on Day 1 followed by a washout period of at least 7 days. In Period 2 on Day 8, same participants will receive Griseofulvin T2: 1 x 250 mg Tablet once followed by a washout period of at least 7 days. In Period 3 on Day 15, same participants will receive Griseofulvin R: 1 x 500 mg Tablet once. All the above-mentioned doses will be administered with 240 +- 2 milliliters (mL) of water at ambient temperature under fed condition. |
| Participants receiving T2RT1 | EXPERIMENTAL | Participants will receive a single oral dose of Griseofulvin T2: 1 x 250 mg Tablet once in Period 1 on Day 1 followed by a washout period of at least 7 days. In Period 2 on Day 8, same participants will receive Griseofulvin R: 1 x 500 mg Tablet once followed by a washout period of at least 7 days. In Period 3 on Day 15, same participants will receive Griseofulvin T1: 1 x 500 mg Tablet once. All the above-mentioned doses will be administered with 240 +- 2 milliliters (mL) of water at ambient temperature under fed condition. |
| Participants receiving RT1T2 | EXPERIMENTAL | Participants will receive a single oral dose of Griseofulvin R: 1 x 500 mg Tablet once in Period 1 on Day 1 followed by a washout period of at least 7 days. In Period 2 on Day 8, same participants will receive Griseofulvin T1: 1 x 500 mg Tablet once followed by a washout period of at least 7 days. In Period 3 on Day 15, same participants will receive Griseofulvin T2: 1 x 250 mg Tablet once. All the above-mentioned doses will be administered with 240 +- 2 milliliters (mL) of water at ambient temperature under fed condition. |
| Name | Type | Description |
|---|---|---|
| Griseofulvin 500 mg | DRUG | Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition. |
| Griseofulvin 250 mg | DRUG | Griseofulvin 250 mg will be administered as an oral tablet once in each treatment period under fed condition. |
| Reference Griseofulvin 500 mg | DRUG | Reference Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition. |
Inclusion Criteria: * Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent. * Participants who are healthy as determined by the investigator or medically qualified designee on a medical evaluation including medical baseline history, physical examination a...
Griseofulvin is an antifungal agent used to treat fungal infections. It is a small molecule being developed by GSK plc. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not been approved for marketing.
GSK plc (ticker: GSK) is developing Griseofulvin. The company is conducting clinical trials to evaluate the drug as an antifungal agent. Griseofulvin is a small molecule in Phase 1 development for infectious disease.
Griseofulvin is in Phase 1 clinical development. It is an investigational antifungal agent being studied by GSK plc. The drug has not been approved by regulatory authorities and remains in early-stage clinical testing.
Griseofulvin has one completed Phase 1 trial, NCT04318535, which studied bioequivalence and dose proportionality of 250 mg and 500 mg tablets under fed conditions. The trial enrolled 36 healthy volunteers in India and was controlled but not double-blinded.
Griseofulvin is the drug name used in clinical trials. No alternative names have been reported for this investigational antifungal agent. It is being developed by GSK plc under the name Griseofulvin.