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NCT01361022
A Randomized, Single-dose, Two-way Cross-over Study to Assess the Bioequivalence of Lendormin Tablets 0.25 mg (Delpharm Reims) vs. Lendormin Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) Administered to Healthy Adult Volunteers
Phase 1 trial testing Lendormin tablet in Healthy in 24 participants. Completed.
1 November 2011
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 August 2011 |
| Primary completion | 1 November 2011 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Lendormin tablet — full drug profile →
- Brotizolam tablet — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 20 to 40, 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.
-
Cmax: Peak drug concentration obtained directly from the data without interpolation
Time frame: One month -
kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Time frame: One month -
Tmax:Time to peak drug concentration obtained directly from the data without interpolation
Time frame: One month -
T 1/2: Plasma half-life estimated by (0.693/kel)
Time frame: One month -
MRT : Mean residence time
Time frame: One month -
AUMC : Area under the ( first) moment plasma concentration - time curve
Time frame: One month
Sponsor's own description
The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
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 NCT01361022
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Boehringer Ingelheim trials
Trials by the same sponsor.
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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 NCT01361022 (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 Boehringer Ingelheim
- Last refreshed: 31 October 2013
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/NCT01361022.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing