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NCT00779051
An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Fasting Conditions
NA trial testing Zolpidem 10mg tablets in Healthy in 36 participants. Completed in 1 October 2005.
1 September 2005
Quick facts
| Lead sponsor | Ranbaxy Laboratories Limited |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 36 |
| Start date | 1 August 2005 |
| Primary completion | 1 September 2005 |
| Estimated completion | 1 October 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Zolpidem 10mg tablets — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Ranbaxy Laboratories Limited — 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
Sponsor's own description
The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under fasting condition
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 NCT00779051
- 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 NCT00779051 (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 Ranbaxy Laboratories Limited
- Last refreshed: 23 October 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/NCT00779051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing