A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects (AZCQ)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01100060
First received: March 26, 2010
Last updated: August 24, 2010
Last verified: August 2010
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Purpose
Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria Prophylaxis |
Drug: azithromycin (AZ) microsphere Drug: test chloroquine (CQ) formulation Drug: azithromycin (AZ) Drug: chloroquine (CQ) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open-Label, Randomized, Single Dose, Parallel Design Study To Estimate The Relative Bioavailability Of Co Administered Formulations Of Azithromycin Microsphere (AZ) And Chloroquine Test Formulation (CQ) Compared With Co Administered Immediate Release Individual AZ And CQ Tablets In Healthy Adult Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Malaria
Drug Information available for:
Chloroquine phosphate
Chloroquine
Chloroquine sulfate
Chloroquine hydrochloride
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- AUClast of azithromycin and chloroquine [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tmax and Cmax of azithromycin and chloroquine. [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]
- AUClast, Tmax, and Cmax of desethylchloroquine. [ Time Frame: Through Day 5 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | April 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.
|
Drug: azithromycin (AZ) microsphere
AZ microsphere (2000 mg) single dose on Day 1.
Other Name: Zmax
Drug: test chloroquine (CQ) formulation
Test CQ formulation, 620 mg CQ base, single dose on Day 1.
|
|
Active Comparator: Group 2
Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.
|
Drug: azithromycin (AZ)
AZ IR 4 x 500 mg tablets, single dose on Day 1.
Other Name: Zithromax
Drug: chloroquine (CQ)
CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
Other Name: Aralen
|
Detailed Description:
Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to first dose.
- Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days.
- Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. "Immediate" is considered "first degree".
- Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis).
- History of intolerance to azithromycin or chloroquine.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01100060 History of Changes |
| Other Study ID Numbers: | A0661195 |
| Study First Received: | March 26, 2010 |
| Last Updated: | August 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Azithromycin chloroquine microsphere pharmacokinetics bioavailability |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials |
Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013