Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rowasa 4 gm · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Mesalamine | EXPERIMENTAL | Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period |
| Rowasa® | ACTIVE_COMPARATOR | Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Rowasa® 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
| Mesalamine 4 gm/60 mL Rectal Enema | DRUG | 1 x 4 gm/60 mL, single-dose |
Inclusion Criteria: * Males and females, 18 years or older, with a body mass index (BMI) of 30 or less. * Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. * Signed informed consent form, which meets all criteria of current FDA r...
Rowasa 4 gm is a small molecule drug being studied in healthy volunteers. It is formulated as a 4 gm/60 mL rectal enema and is currently in Phase 1 clinical development. The drug is being investigated for use in healthy individuals, with one completed clinical trial involving 72 participants.
Rowasa 4 gm is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development and has completed one clinical trial in healthy volunteers.
Rowasa 4 gm is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed one Phase 1 clinical trial, which was conducted in the United States with 72 healthy volunteers.
Rowasa 4 gm has one completed clinical trial registered under NCT00840203, titled "Mesalamine 4 gm/60 mL Rectal Enema." This Phase 1 trial enrolled 72 healthy volunteers in the United States and was an active-controlled, randomized study. The trial is now completed.
Rowasa 4 gm contains mesalamine as its active ingredient, as indicated by the clinical trial title "Mesalamine 4 gm/60 mL Rectal Enema." The drug is being studied as a rectal enema formulation for use in healthy volunteers, and it is currently in Phase 1 clinical development.