Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium bromide 400 μg · 2 trials · 2 indications
Characterization of Cmax, taken directly from the individual concentration-time curve after single dose or multiple dose.
Characterization of Tmax, taken directly from the individual concentration-time curve after single dose or multiple dose.
Characterization of AUCinf (single dose). Area under the concentration time curve from time zero extrapolated to infinity. AUC(0-∞) is estimated by AUC(last) + Clast/λz where Clast is the last observed quantifiable concentration.
The AUC(0-12) of aclidinium bromide and its metabolites after single dose of aclidinium bromide in healthy Chinese participants is investigated. Description of the AUC(0-12), partial area under the concentration- time curve in the dose interval after single dose or multiple dose.
Characterization of AUClast, taken directly from the individual concentration-time curve after single dose or multiple dose.
Characterization of t½λz, of aclidinium bromide and its metabolites after single and multiple doses of aclidinium bromide in healthy Chinese participants.
Characterization of CL/F, of aclidinium bromide after single and multiple doses of aclidinium bromide in healthy Chinese participants.
Characterization of Vz/F, of aclidinium bromide after single and multiple doses of aclidinium bromide in healthy Chinese participants.
Characterization of MRTinf, of aclidinium bromide after single dose of aclidinium bromide in healthy Chinese participants.
Characterization of Cmin, taken directly from the individual concentration-time curve after single dose or multiple dose.
Characterization of Cavg, of aclidinium bromide and its metabolites after multiple doses of aclidinium bromide in healthy Chinese participants.
Characterization of Rac(Cmax), of aclidinium bromide and its metabolites after multiple doses of aclidinium bromide in healthy Chinese participants. Rac(Cmax) is caculated as a ratio for Cmax estimated as (ratio of Css,max on Day 9/Cmax on Day 1).
Characterization of Rac(Cmin), of aclidinium bromide and its metabolites after multiple doses of aclidinium bromide in healthy Chinese participants. Rac(Cmin) is calculated as ratio for Cmin estimated as (ratio of Css, Cmin on Day 9/ Cmin on Day 1)
Characterization of Rac(AUC), of aclidinium bromide and its metabolites after multiple doses of aclidinium bromide in healthy Chinese participants. Rac(AUC), calculated as ratio of AUC(0-12) on day 9 and AUC0-12 on Day 1.
Characterization of %Fluc, of aclidinium bromide and its metabolites after multiple doses of aclidinium bromide in healthy Chinese participants. The %Fluc index is estimated as 100 x (Cmax- Cmin)/Cav.
| Arm | Type | Description |
|---|---|---|
| Aclidinium 400 μg bid | EXPERIMENTAL | Aclidinium bromide 400 μg twice-daily by inhalation |
| Tiotropium 18 μg once-daily | ACTIVE_COMPARATOR | Tiotropium 18 μg once-daily by inhalation |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Aclidinium Bromide 400 μg | EXPERIMENTAL | One inhalation from the 400 μg Aclidinium Bromide inhaler. |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide 400 μg bid | DRUG | Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days. |
| Tiotropium 18 μg once-daily | DRUG | Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days. |
| Placebo | DRUG | Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days. |
| Aclidinium Bromide 400 μg | DRUG | Aclidinium Bromide 400 μg BID inhalation powder. One oral inhalation via Genuair® dry powder inhaler (DPI) |
Inclusion Criteria: * Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD guidelines). * Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%. * Current or ex smokers of 10 pack-years. Exclusion Criteria: * Patients wit...
Aclidinium Bromide 400 μg is an investigational small molecule being studied for use in Chronic Obstructive Pulmonary Disease (COPD) and in healthy volunteers. It is developed by AstraZeneca PLC (AZN) and is currently in Phase 1 clinical development.
Aclidinium Bromide 400 μg is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being investigated for its effects in patients with Chronic Obstructive Pulmonary Disease (COPD) and in healthy volunteers.
Aclidinium Bromide 400 μg is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development.
Aclidinium Bromide 400 μg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and pharmacokinetics.
Aclidinium Bromide 400 μg has been studied in two completed clinical trials. NCT00868231 was a Phase 2 study in COPD patients in Germany, and NCT03276052 was a Phase 1 study in healthy Chinese participants. Both trials have been completed.
Aclidinium Bromide 400 μg is a specific dosage form of the drug aclidinium bromide. The 400 μg strength is being studied in clinical trials for Chronic Obstructive Pulmonary Disease (COPD) and in healthy volunteers.