drugset / Trial / NCT00649688

Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg

NCT00649688

Phase 1 Completed 32 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fasting conditions.

Timeline

Start
2003-01
Primary completion
2003-02
Completion
2003-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 50 mg Oral
Comparator Metoprolol Other / unclassified 100 mg Oral

Indications

No indication recorded.