Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lopressor HCT 100 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg |
| 2 | ACTIVE_COMPARATOR | Lopressor HCT® Tablets 100/50 mg |
| Name | Type | Description |
|---|---|---|
| Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg | DRUG | 100/50mg, single dose fed |
| Lopressor HCT® Tablets 100/50 mg | DRUG | 100/50mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...
Lopressor HCT 100 is a combination tablet being studied in healthy volunteers. It contains metoprolol tartrate and hydrochlorothiazide, and is being evaluated in Phase 1 bioavailability studies comparing the generic formulation to the reference product. The studies are conducted in the United States with healthy adult participants.
Lopressor HCT 100 is developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the pharmacokinetics of the combination tablet in healthy volunteers.
Lopressor HCT 100 is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for marketing based on the available clinical trial data.
Lopressor HCT 100 has been studied in two completed Phase 1 trials: NCT00649233, a food study comparing metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Lopressor HCT 100/50 mg tablets, and NCT00649688, a fasting study with the same comparison. Each trial enrolled 32 healthy participants in the United States.
Lopressor HCT 100 is a brand-name combination tablet containing metoprolol tartrate and hydrochlorothiazide. The clinical trials compare the generic metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Lopressor HCT 100/50 mg tablets to assess bioequivalence.