Trials / Unknown
UnknownNCT05654090
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Cefoperazone Sodium and Sulbactam Sodium Combination (1/1 g/Vial) After Intravenous Infusion of 1 g Cefoperazone Sodium and 1 g Sulbactam Sodium in Healthy Volunteers Under Fasting Conditions
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd. · Industry
- Sex
- —
- Age
- 20 Years – 20 Years
- Healthy volunteers
- Accepted
Summary
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g sulbactam sodium in healthy volunteers under fasting conditions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cefoperazone sodium and sulbactam sodium | Pharmacokinetic study under fasting conditions |
Timeline
- Start date
- 2022-08-25
- Primary completion
- 2022-11-18
- Completion
- 2023-02-20
- First posted
- 2022-12-16
- Last updated
- 2023-02-01
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05654090. Inclusion in this directory is not an endorsement.