Last reviewed · How we verify
NCT00647959
Single-Dose Fasting Bioequivalence Study of Doxycycline Monohydrate Tablets (150 mg; Mylan) and Adoxa Tablets (150 mg; Par) in Healthy Volunteers
Phase 1 trial testing Doxycycline Tablets, 150mg in Healthy in 36 participants. Completed in 1 April 2006.
1 March 2006
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 | 36 |
| Start date | 1 March 2006 |
| Primary completion | 1 March 2006 |
| Estimated completion | 1 April 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Doxycycline Tablets, 150mg — full drug profile →
- Adoxa Tablets 150 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's doxycycline monohydrate 150 mg tablets to Par's Adoxa® 150 mg tablets following a single, oral 150 mg (1 x 150 mg) dose administered under fasting 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 NCT00647959
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Mylan Pharmaceuticals Inc trials
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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 NCT00647959 (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/NCT00647959.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing