BioequivalencePhase 1NCT03621072
Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France
A Phase 1 study testing Fluconazole 150mg Capsule Originator and Fluconazole 150mg Capsule Localized Originator 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 bioequivalence study to support the program and to demonstrate the bioequivalence between the 150 mg fluconazole capsule… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Fluconazole 150mg Capsule Originator and Fluconazole 150mg Capsule Localized Originator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 20 Jul 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male and 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 (BP) and pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.
- Body Mass Index (BMI) of 18 to 28 kg/m**2, inclusive; 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
- 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 regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 150 mL of wine or 360 mL of beer or (45 mL of hard liquor) within 6 months of Screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day within 3 months of Screening; a positive urine nicotine test.
- Treatment with an investigational drug (which has not been approved for registration) within 30 days preceding the first dose of investigational product. If the investigational drug has a long elimination half-life, the washout period will be longer with a recommendation of five elimination half-lives.
Show all 18Show fewer
- Screening 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 and dietary supplements within 7 days prior to the first dose of investigational product. If the concomitant medication has a long elimination half-life, the washout period will be longer with a recommendation of five elimination half-lives. 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.
- Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- History of hypersensitivity to fluconazole or any components of its formulation.
- History of hepatitis B or hepatitis C; positive testing for hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), hepatitis C antibody (HCVAb), treponema pallidum antibody (TPPA) or human immunodeficiency virus (HIV) antibody.
- Unwilling or unable to comply with the criteria in the Lifestyle Guidelines described in this protocol.
- 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.
About this study
Official title: AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 2-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER FAREVA, AMBOISE, FRANCE) 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 bioequivalence study to support the program and to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 2-way crossover study will enroll approximately 18 subjects for each condition. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
Read the detailed description
This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA), for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 150 mg capsule is the approved highest strength of capsule formulation in China. The 150 mg dose was selected for evaluation in this study as it is one of the commonly used clinically approved doses. The primary objective is to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) administered as a single oral dose in healthy Chinese subjects under fasted and fed conditions. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and peak plasma concentrations (Cmax).
The secondary objective is to evaluate the safety and tolerability of fluconazole administered as a single oral dose of 150 mg capsule manufactured at Pfizer Dalian, China and 150 mg capsule manufactured at Pfizer Fareva, Amboise, France in healthy Chinese subjects under fasted and fed conditions. The secondary endpoint is adverse events (AEs). Other endpoints include time to reach Cmax (Tmax) of fluconazole, safety laboratory tests and vital signs.
In each group, subjects will be randomized to one of the 2 treatment sequences. Each treatment sequence will consist of 2 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 fluconazole in plasma will be collected at pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 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
- Fluconazole 150mg Capsule Originator, Fluconazole 150mg Capsule Localized Originator
- Keywords
- Fluconazole, 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.
Fluconazole 150mg Capsule OriginatorDrug
Also called The originator, Reference
150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France
Fluconazole 150mg Capsule Localized OriginatorDrug
Also called The localized originator, Experimental
150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China
| Study group | Role | What they receive |
|---|---|---|
| Reference | Other | Fluconazole 150mg Capsule Originator Receives: Drug: Fluconazole 150mg Capsule Originator |
| Experimental | Experimental | Fluconazole 150mg Capsule Localized Originator Receives: Drug: Fluconazole 150mg Capsule Localized Originator |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 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 plasma concentration among observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose
Measured: 0-72hours
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 18 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 posted8 Aug 2018
- Study start3 Jun 2019
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, 2-way crossover bioequivalence study under fasted and fed conditions in healthy Chinese subjects. Under each condition, subjects will be randomized to one of the 2 treatment sequences. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 14 days between each period. For sequence 1, first localized originator and then originator will be administered. The order for sequence 2 is originator and localized originator.
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT03621072
- Sponsor's protocol ID
- A0561025
- Status last verified
- Jul 2021
- First submitted
- 3 Aug 2018
- Last updated
- 16 Jul 2021
- Results posted
- 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.
Publications
Chen N, He Q, Ma Y, Liu S, Wei H, Peng A. Pharmacokinetics and Bioequivalence of Fluconazole Capsules Manufactured in France and China in Healthy Chinese Participants: Open-Label, Randomized, Single-Dose, 2-Way, Crossover Bioequivalence Study Under Fasted and Fed Conditions. Clin Pharmacol Drug Dev. 2023 Jun;12(6):572-578. doi: 10.1002/cpdd.1248. Epub 2023 Apr 10.
PubMed 37036155
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 2-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER FAREVA, AMBOISE, FRANCE) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS
- ClinicalTrials.gov ID
- NCT03621072
- Acronym / sponsor ID
- A0561025
- Conditions
- Bioequivalence
- Keywords
- Fluconazole, Bioequivalence, Phase I, Chinese, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 8 Aug 2018 (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 bioequivalence study to support the program and to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 2-way crossover study will enroll approximately 18 subjects for each condition. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
Detailed description
This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA), for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 150 mg capsule is the approved highest strength of capsule formulation in China. The 150 mg dose was selected for evaluation in this study as it is one of the commonly used clinically approved doses. The primary objective is to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) administered as a single oral dose in healthy Chinese subjects under fasted and fed conditions. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and peak plasma concentrations (Cmax).
The secondary objective is to evaluate the safety and tolerability of fluconazole administered as a single oral dose of 150 mg capsule manufactured at Pfizer Dalian, China and 150 mg capsule manufactured at Pfizer Fareva, Amboise, France in healthy Chinese subjects under fasted and fed conditions. The secondary endpoint is adverse events (AEs). Other endpoints include time to reach Cmax (Tmax) of fluconazole, safety laboratory tests and vital signs.
In each group, subjects will be randomized to one of the 2 treatment sequences. Each treatment sequence will consist of 2 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 fluconazole in plasma will be collected at pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 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, 2-way crossover bioequivalence study under fasted and fed conditions in healthy Chinese subjects. Under each condition, subjects will be randomized to one of the 2 treatment sequences. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 14 days between each period. For sequence 1, first localized originator and then originator will be administered. The order for sequence 2 is originator and localized originator.
| Arm | Type | Receives |
|---|---|---|
| Reference | Other | Drug: Fluconazole 150mg Capsule OriginatorFluconazole 150mg Capsule Originator |
| Experimental | Experimental | Drug: Fluconazole 150mg Capsule Localized OriginatorFluconazole 150mg Capsule Localized Originator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese male and 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 (BP) and pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.
- Body Mass Index (BMI) of 18 to 28 kg/m**2, inclusive; 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)
Key exclusion criteria (18 listed)
- 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 regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 150 mL of wine or 360 mL of beer or (45 mL of hard liquor) within 6 months of Screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day within 3 months of Screening; a positive urine nicotine test.
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 |
|---|---|---|
| Fluconazole 150mg Capsule OriginatorAlso: The originator, Reference150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France | Drug | Reference |
| Fluconazole 150mg Capsule Localized OriginatorAlso: The localized originator, Experimental150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China | Drug | Experimental |
Primary outcome
AUC0-72
Time frame: 0-72 hours
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods
Cmax
Time frame: 0-72hours
Maximum plasma concentration among observed plasma concentrations at time points 0 (prior-dose), 0.25, 0.5, 1, 1.5, 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 18 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 16 Jul 2021.
- Derived from this study: PubMed 37036155Chen N, He Q, Ma Y, Liu S, Wei H, Peng A. Pharmacokinetics and Bioequivalence of Fluconazole Capsules Manufactured in France and China in Healthy Chinese Participants: Open-Label, Randomized, Single-Dose, 2-Way, Crossover Bioequivalence Study Under Fasted and Fed Conditions. Clin Pharmacol Drug Dev. 2023 Jun;12(6):572-578. doi: 10.1002/cpdd.1248. Epub 2023 Apr 10.
- 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 Fluconazole 150mg Capsule Originator and Fluconazole 150mg Capsule Localized Originator 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 5 inclusion and 18 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 16 Jul 2021. 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?
On the ClinicalTrials.gov record for NCT03621072, which also lists 1 linked publication.
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 16 Jul 2021.