To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

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Sandoz

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00881153
AA17502

Details and patient eligibility

About

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

1
Experimental group
Description:
Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
Treatment:
Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
2
Active Comparator group
Description:
Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)
Treatment:
Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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