A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions

NCT00830336 | Completed Phase 1 Results

• 1 other identifier: R05-1375
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 168 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 168 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Bioequivalence based on AUC0-t

  Blood samples collected over 168 hour period

Study Arms (2)

Azithromycin (test)

EXPERIMENTAL

Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period

Drug: Azithromycin

Zithromax® (reference)

ACTIVE COMPARATOR

Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period

Drug: Zithromax®

Interventions

Azithromycin DRUG

Oral Suspension

Azithromycin (test)

Zithromax® DRUG

Oral Suspension

Also known as: Zithromax® for Oral Suspension

Zithromax® (reference)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30.
• Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing.
• Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
• Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
• The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
• The screening clinical laboratory procedures will include:
• HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
• CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
• HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens
• URINALYSIS: by dipstick; full microscopic examination if dipstick positive
• URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
• SERUM PREGNANCY SCREEN (female subjects only)
• If female and:
• Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
• Is postmenopausal for at least 1 year; or

You may not qualify if:

• Subjects with a recent history of drug or alcohol addiction or abuse.
• Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
• Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
• Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
• Subjects demonstrating a positive drug abuse screen when screened for this study.
• Female subjects demonstrating a positive pregnancy screen.
• Female subjects who are currently breastfeeding.
• Subjects with a history of allergic response(s) to azithromycin or related drugs.
• Subjects with a history of clinically significant allergies including drug allergies.
• Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
• Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
• Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
• Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
• Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
• Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

Azithromycin; Suspensions

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm. D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: October 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 20, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

US (1)