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NCT00652795
Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions
Phase 1 trial testing Doxycycline Monohydrate in To Determine Bioequivalence Under Fasting Conditions in 36 participants. Completed in 1 September 2004.
1 September 2004
Quick facts
| Lead sponsor | Par Pharmaceutical, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 36 |
| Start date | 1 July 2004 |
| Primary completion | 1 September 2004 |
| Estimated completion | 1 September 2004 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Doxycycline Monohydrate
- Monodox — full drug profile →
Conditions studied
- To Determine Bioequivalence Under Fasting Conditions — all drugs for To Determine Bioequivalence Under Fasting Conditions →
Sponsor
Par Pharmaceutical, Inc. — full company profile →
Who can join
18 and older, any sex, with To Determine Bioequivalence Under Fasting Conditions. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Rate and extent of absorption
Time frame: 24 hours
Sponsor's own description
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
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 NCT00652795
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT00652795 (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 Par Pharmaceutical, Inc.
- Last refreshed: 1 April 2008
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/NCT00652795.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing