BioequivalencePhase 1NCT03353480
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
A Phase 1 study testing Azithromycin Tablet manufactured in China and Azithromycin Tablet manufactured in US in people with Bioequivalence, run by Pfizer at 1 site in China.
Trial summary
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a reference scaled bioequivalence study to support the program and to demonstrate the bioequivalence between the 250 mg azithromycin… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Azithromycin Tablet manufactured in China and Azithromycin Tablet manufactured in US
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2017to 26 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy Chinese male and female subjects, between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.
- BMI of 18 to 28 kg/m2; and a total body weight ≥50 kg for males and ≥45 kg for females.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
Who cannot join
- Subjects with any of the following characteristics/conditions will not be included in the study:
- 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 the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen, history of drug abuse within the past 5 years.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 100 mL of wine or 285 mL of beer or 25 mL of hard liquor) within 3 months of Screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day within 3 months prior to Screening.
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- Treatment with an investigational drug within 3 months preceding the first dose of investigational product.
- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS complex >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
- Female subjects of childbearing potential and fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- Female subjects who are breastfeeding or with positive pregnancy test at Screening and during the study period.
- Use of prescription or nonprescription drugs, dietary supplements and herbal medicines within 14 days prior to Screening. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor. Taking any medicinal product that changes the activity of hepatic enzymes within 28 days prior to Screening, such as a strong CYP3A4 inducer (eg, St. John's Wort).
- Blood donation (excluding plasma donations) or loss of blood of approximately 450 mL or more within 3 months prior to Screening.
- History of hypersensitivity to azithromycin or any components of its formulation.
- Use of special diet (including dragon fruit, mango, citrus, etc.), strenuous activities or other factors that may affect the disposition of the study medication within 14 days prior to Screening.
- Use of chocolate, food or beverages containing caffeine or xanthine within 48 hours prior to dosing.
- Use of products containing alcohol within 48 hours prior to dosing.
- Intolerance of the standard high fat breakfast, which is only applicable to the subjects participating in Group 2 (fed condition).
- History of HIV, hepatitis B, or hepatitis C; positive testing for HIV, HepBsAg, HepBcAb, HCVAb, or TPPA.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section.
- Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University/Phase I Clinical Trials Unit
Changchun, Jilin, 130021
About this study
Official title: AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER BARCELONETA, UNITED STATES) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a reference scaled bioequivalence study to support the program and to demonstrate the bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 3-way crossover study will enroll approximately 33 subjects for each condition. The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
Read the detailed description
This is a reference scaled bioequivalence study to support a generic consistency evaluation program, initiated by CFDA in 2016, for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 250 mg tablet is the approved strength. The primary objective is to demonstrate the bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under fasted (Group 1) and fed (Group 2) conditions. Approximately 33 Chinese healthy subjects will be enrolled for each group.
The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
The secondary objective is to evaluate the safety and tolerability of azithromycin administered as a single oral dose of 250 mg tablet manufactured at Pfizer Dalian, China and 250 mg tablet manufactured at Pfizer Barceloneta, Puerto Rico, US in healthy Chinese subjects under fasted and fed conditions. And the secondary endpoint is adverse events (AEs). Other endpoints include Tmax of azithromycin, safety laboratory tests and vital signs.
In each group, subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 periods, separated by a washout period of at least 14 days between each period.
On Day 1 of each period in both groups, each subject will be administered investigational product at approximately 8:00 AM (± 2 hours). Blood samples for the analysis of azithromycin in serum will be collected at pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 and 72 hours post dose in each period. Vital signs, physical examination, laboratory tests and 12-lead electrocardiogram (ECG) will be performed at specified times. Tolerability and safety will be assessed for all treatments by monitoring AEs.
- Conditions
- Bioequivalence
- Being tested
- Azithromycin Tablet manufactured in China, Azithromycin Tablet manufactured in US
- Keywords
- Azithromycin tablet, Bioequivalence, Phase I, Chinese, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Tablet manufactured in ChinaDrug
Also called The localized originator, Experimental
250 mg Azithromycin Tablet manufactured in China
Azithromycin Tablet manufactured in USDrug
Also called The originator, Reference
250 mg Azithromycin Tablet manufactured in US
| Study group | Role | What they receive |
|---|---|---|
| Reference | Other | 250mg Azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US Receives: Drug: Azithromycin Tablet manufactured in US |
| Experimental | Experimental | 250mg Azithromycin tablet manufactured at Pfizer Dalian, China Receives: Drug: Azithromycin Tablet manufactured in China |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72
Area under the serum concentration-time profile from time zero to 72 hours post dose based on observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods
Measured: 0-72 hours
Cmax
Maximum serum concentration among observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose
Measured: 0-72 hours
Secondary outcomes (1)
Adverse Events
All observed or volunteered safety events regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported during study.
Measured: Day 1 to Day 32 or early termination, plus at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start20 Dec 2017
- Primary completion29 Jan 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, randomized, single-dose, 3-way crossover, reference scaled bioequivalence study under fasted and fed conditions in healthy Chinese subjects. Under each condition, subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 periods, separated by a washout period of at least 14 days between each period. For sequence 1, first localized originator, then originator and finally originator will be administered. The order for sequence 2 is originator, localized originator and originator. The order for sequence 3 is originator, originator and localized originator.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353480
- Sponsor's protocol ID
- A0661212
- Status last verified
- Feb 2019
- First submitted
- 21 Nov 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER BARCELONETA, UNITED STATES) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS
- ClinicalTrials.gov ID
- NCT03353480
- Acronym / sponsor ID
- A0661212
- Conditions
- Bioequivalence
- Keywords
- Azithromycin tablet, Bioequivalence, Phase I, Chinese, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a reference scaled bioequivalence study to support the program and to demonstrate the bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 3-way crossover study will enroll approximately 33 subjects for each condition. The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
Detailed description
This is a reference scaled bioequivalence study to support a generic consistency evaluation program, initiated by CFDA in 2016, for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 250 mg tablet is the approved strength. The primary objective is to demonstrate the bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under fasted (Group 1) and fed (Group 2) conditions. Approximately 33 Chinese healthy subjects will be enrolled for each group.
The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
The secondary objective is to evaluate the safety and tolerability of azithromycin administered as a single oral dose of 250 mg tablet manufactured at Pfizer Dalian, China and 250 mg tablet manufactured at Pfizer Barceloneta, Puerto Rico, US in healthy Chinese subjects under fasted and fed conditions. And the secondary endpoint is adverse events (AEs). Other endpoints include Tmax of azithromycin, safety laboratory tests and vital signs.
In each group, subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 periods, separated by a washout period of at least 14 days between each period.
On Day 1 of each period in both groups, each subject will be administered investigational product at approximately 8:00 AM (± 2 hours). Blood samples for the analysis of azithromycin in serum will be collected at pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 and 72 hours post dose in each period. Vital signs, physical examination, laboratory tests and 12-lead electrocardiogram (ECG) will be performed at specified times. Tolerability and safety will be assessed for all treatments by monitoring AEs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, single-dose, 3-way crossover, reference scaled bioequivalence study under fasted and fed conditions in healthy Chinese subjects. Under each condition, subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 periods, separated by a washout period of at least 14 days between each period. For sequence 1, first localized originator, then originator and finally originator will be administered. The order for sequence 2 is originator, localized originator and originator. The order for sequence 3 is originator, originator and localized originator.
| Arm | Type | Receives |
|---|---|---|
| Reference | Other | Drug: Azithromycin Tablet manufactured in US250mg Azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US |
| Experimental | Experimental | Drug: Azithromycin Tablet manufactured in China250mg Azithromycin tablet manufactured at Pfizer Dalian, China |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy Chinese male and female subjects, between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.
- BMI of 18 to 28 kg/m2; and a total body weight ≥50 kg for males and ≥45 kg for females.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (22 listed)
- Subjects with any of the following characteristics/conditions will not be included in the study:
- 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 the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen, history of drug abuse within the past 5 years.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 100 mL of wine or 285 mL of beer or 25 mL of hard liquor) within 3 months of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Tablet manufactured in ChinaAlso: The localized originator, Experimental250 mg Azithromycin Tablet manufactured in China | Drug | Experimental |
| Azithromycin Tablet manufactured in USAlso: The originator, Reference250 mg Azithromycin Tablet manufactured in US | Drug | Reference |
Primary outcome
AUC0-72
Time frame: 0-72 hours
Area under the serum concentration-time profile from time zero to 72 hours post dose based on observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods
Cmax
Time frame: 0-72 hours
Maximum serum concentration among observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose
1 secondary outcome
Adverse Events
Time frame: Day 1 to Day 32 or early termination, plus at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin Tablet manufactured in China and Azithromycin Tablet manufactured in US in people with Bioequivalence, run by Pfizer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-72 (time frame: 0-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.