Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tramodol Extended-Release (ER)
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 developed by Johnson & Johnson (ticker JNJ). It is being studied in a Phase 1 clinical program, with one completed trial to date. The specific medical conditions it is intended to treat have not been disclosed.
Tramodol is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the drug's clinical development program, which currently consists of a single completed Phase 1 study.
Tramodol is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials listed for the drug. It is an investigational agent and has not been approved by the FDA.
Tramodol has been evaluated in one completed Phase 1 trial, NCT01800682, titled a pharmacokinetic study to evaluate the dose-proportionality of tramadol extended-release in healthy participants. The trial enrolled 30 healthy volunteers in the United States and was randomized and controlled.
Yes, Tramodol Extended-Release (ER) is an alternative name for Tramodol. Both names refer to the same Johnson & Johnson small molecule candidate. The completed Phase 1 pharmacokinetic study, NCT01800682, was conducted using the extended-release formulation in healthy participants.