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NCT00649233
Single-Dose Food In Vivo Bioequivalence Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets (100/50 mg; Mylan) to Lopressor HCT® Tablets (100/50 mg; Novartis) in Healthy Volunteers
Phase 1 trial testing Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg in Healthy in 32 participants. Completed in 1 February 2003.
1 February 2003
Quick facts
| Lead sponsor | Mylan Pharmaceuticals Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 32 |
| Start date | 1 January 2003 |
| Primary completion | 1 February 2003 |
| Estimated completion | 1 February 2003 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg — full drug profile →
- Lopressor HCT® Tablets 100/50 mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Mylan Pharmaceuticals Inc — full company profile →
Who can join
18 and older, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bioequivalence
Time frame: within 30 days
Sponsor's own description
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 fed conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00649233
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00649233 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mylan Pharmaceuticals Inc
- Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00649233.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing