Status:
COMPLETED
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release cl...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Sex: Males or females who are surgically sterile or have been post-menopausal for at least 6 months; similar proportions of each preferred.
- Age: At least 18 years.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subjects may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Laboratory Tests:
- Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Nz, K, Cl), fasting blood glucose, BUN, bilirubin,m creatinine, AST, ALT, LD, alkaline phosphatase and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in. Post-menopausal females will have an FSH (Follicle Stimulating Hormone) level performed to confirm post-menopausal status.
- Laboratory values which are greater than ±20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
- Electrocardiogram
- A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- Subjects must read and sign the Consent Form.
- Exclusion Criteria
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study:
- History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of treatment for any gastrointestinal disorder within the past 5 years.
- History of treatment for asthma within the past five (5) years.
- History of diarrhea within 24 hours prior to dosing.
- Females who are pregnant or lactating.
- History of hypersensitivity to clarithromycin or any macrolide antibiotic.
- C. Conditions upon screening which might contraindicate or require that caution be used in the administration of dexmethylphenidate hydrochloride, including:
- Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
- Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
- Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.). Three (3) consecutive months abstinence is required.
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00840411
Start Date
September 1 2002
End Date
October 1 2002
Last Update
August 19 2024
Active Locations (1)
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1
Gateway Medical Research
Saint Charles, Missouri, United States, 63301