Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tramodol · 1 trial · 1 indication
The Cmax is the maximum plasma concentration.
The Tmax is time to reach the maximum plasma concentration.
The AUC(last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
The AUC(infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Elimination half-life associated with the terminal slope (lambda\[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
| Arm | Type | Description |
|---|---|---|
| Tramodol Extended-release (ER), 25 milligram (mg) | EXPERIMENTAL | Tramodol ER, 25 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days). |
| Tramodol ER, 50 mg | EXPERIMENTAL | Tramodol ER, 50 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days). |
| Tramodol ER, 100 mg | EXPERIMENTAL | Tramodol ER, 100 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days). |
| Name | Type | Description |
|---|---|---|
| Tramodol Extended-Release (ER) | DRUG | Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days). |
Inclusion Criteria: * Females with negative pregnancy test at Screening and on Day -1 of each treatment period * Postmenopausal Females (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control * Body mass...
Tramodol is an investigational small molecule being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to assess its pharmacokinetic properties, specifically the dose-proportionality of the extended-release (ER) formulation. The drug is not approved and remains in clinical development.
Tramodol is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this investigational drug in the United States.
Tramodol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is completed and was designed to evaluate the dose-proportionality of the extended-release formulation in healthy participants.
Tramodol has one completed Phase 1 clinical trial registered under NCT01800682. The study, titled "A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramodol (ULTRAM) Extended-Release (ER) in Healthy Participants," enrolled 30 healthy volunteers in the United States. The trial was controlled but not double-blinded.
Tramodol is also known as ULTRAM in the context of the extended-release formulation being studied. The clinical trial NCT01800682 refers to the drug as Tramodol (ULTRAM) Extended-Release, indicating that ULTRAM is a brand name associated with this investigational drug.