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To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

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Sandoz

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00881179
B013721

Details and patient eligibility

About

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Enrollment

24 patients

Sex

All

Ages

18 to 59 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)

24 participants in 2 patient groups

1
Experimental group
Description:
Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
Treatment:
Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
2
Active Comparator group
Description:
Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
Treatment:
Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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