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NCT01064115
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg in Healthy Adult Human Male Subjects Under Fed Conditions.
Phase 1 trial testing Cetirizine Hydrochloride in Healthy in 30 participants. Completed in 1 February 2006.
1 January 2006
Quick facts
| Lead sponsor | Dr. Reddy's Laboratories Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2006 |
| Primary completion | 1 January 2006 |
| Estimated completion | 1 February 2006 |
Drugs / interventions tested
- Cetirizine Hydrochloride — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Dr. Reddy's Laboratories Limited
Who can join
Adults 18 to 45, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg
Time frame: 2 months
Sponsor's own description
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects 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 NCT01064115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Healthy
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Other Dr. Reddy's Laboratories Limited trials
Trials by the same sponsor.
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- NCT03554772 — Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15 · Phase 2 · completed
- NCT03421197 — A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) · Phase 2 · completed
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 NCT01064115 (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 Dr. Reddy's Laboratories Limited
- Last refreshed: 4 February 2010
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/NCT01064115.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing