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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01311505 | Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®) | PHASE1 | COMPLETED | 21 | — | — | Apr 1, 2011 | May 1, 2011 | Jul 30, 2012 | 1 | Philippines |
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Test |
| B | ACTIVE_COMPARATOR | Reference |
| Name | Type | Description |
|---|---|---|
| Myrin© 2 (Rifampicin + Isoniazid) | DRUG | Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg |
| Rimactane® (Rifampicin) | DRUG | One (1) capsule of Rifampicin 300 mg |
Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. * Subjects willing and able to comply with scheduled ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |