Trials / Completed
CompletedNCT00882570
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fasting State
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years – 56 Years
- Healthy volunteers
- Accepted
Summary
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) | |
| DRUG | Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2009-04-16
- Last updated
- 2017-03-29
Source: ClinicalTrials.gov record NCT00882570. Inclusion in this directory is not an endorsement.