Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMB new formulation · 1 trial · 1 indication
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who provided PK parameter data.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| AMB dispersed in water/AMB oral tablet/reference AMB | EXPERIMENTAL | Eligible participants will receive a single oral dose of 5 milligram (mg) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg AMB oral tablet in treatment period 2. In treatment period 3, participants will receive a single oral dose of reference 5 mg AMB tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB oral tablet/reference AMB/AMB dispersed in water | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB oral tablet during treatment period 1 followed by single dose of reference 5 mg AMB oral tablet in treatment period 2. In treatment period 3, participants will receive single dose of 5 mg AMB tablet dispersed in water. There will be a washout period of 7 days between doses in each treatment period. |
| Reference AMB/AMB dispersed in water/AMB oral tablet | EXPERIMENTAL | Eligible participants will receive single dose of reference 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB tablet dispersed in water in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB dispersed in water/reference AMB/AMB oral tablet | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB tablet dispersed in water during treatment period 1 followed by single dose of reference 5 mg AMB oral tablet in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB oral tablet/AMB dispersed in water/reference AMB | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB tablet dispersed in water in treatment period 2. In treatment period 3 participants will receive single dose of reference 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| Reference AMB/AMB oral/AMB dispersed in water | EXPERIMENTAL | Eligible participants in this arm will receive single dose of reference 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB oral tablet in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB tablet dispersed in water There will be a washout period of 7 days between doses in each treatment period. |
| Name | Type | Description |
|---|---|---|
| AMB new formulation (1 mg) | DRUG | AMB tablets will be available at a unit dose strength of 1 mg. Participants will orally administer 5 tablets of 1 mg unit dose. |
| Reference AMB (5 mg) | DRUG | AMB reference tablet will be available as film-coated tablet at unit dose strength of 5 mg. Participants will orally administer 1 tablet of 5 mg unit dose |
Inclusion Criteria: * Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring. ...
AMB new formulation is an investigational small molecule being developed for pulmonary hypertension, a condition of high blood pressure in the arteries of the lungs. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AMB new formulation is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
AMB new formulation is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the relative bioavailability of marketed and lower dose ambrisentan in healthy adult participants. The drug remains investigational and is not yet approved for any use.
AMB new formulation has one completed clinical trial, NCT04095286, titled 'Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants.' This Phase 1 study enrolled 29 participants in the United Kingdom and was a controlled, randomized trial.
AMB new formulation is a new formulation of ambrisentan, a drug used for pulmonary hypertension. The clinical trial NCT04095286 compares the relative bioavailability of the marketed form and a lower dose formulation of ambrisentan, indicating that AMB new formulation is a modified version of the existing drug.