Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01800682 | A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy Participants | PHASE1 | COMPLETED | 30 | — | — | Jul 1, 2011 | Sep 1, 2011 | Feb 28, 2013 | 1 | United States |
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...