Healthy VolunteersPhase 1NCT04445922
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition
A Phase 1 study testing test-anastrozole tablet (Salutas Pharma GmbH) and reference-anastrozole tablet in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fed conditions to assess the bioequivalence between two formulations of Anastrozole. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- test-anastrozole tablet (Salutas Pharma GmbH) and reference-anastrozole tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2020to 30 Oct 2020
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Postmenopausal volunteers aged between 18 and 65 years old.
- The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
- The subjects have no family planning within 6 months and could select contraceptive method.
- Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.
Who cannot join
- Meet the diagnostic criteria for osteoporosis.
- Subjects with vaginal bleeding.
- blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
- any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
- smoking more than 5 cigarettes per day during the 3 months prior to screening;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition: A Open-label, Randomized,Single- Dose,Two-period, Two-group, Crossover Study
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fed conditions to assess the bioequivalence between two formulations of Anastrozole.
Read the detailed description
Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese female subjects were randomized to receive a single dose of 1.0-mg test and reference formulations of anastrozole within 30 min after beginning the consumption of a recommended high-fat, high-calorie breakfast (150 calories from protein, 250 calories from carbohydrate, and 500-600 calories from fat; total calories approximately 800-1000).This was repeated two times, separated by a 21-day washout period.Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1.5, 2, 2h20min, 2h40min, 3, 3.5, 4, 4.5, 5, 7, 12, 24, 48 and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞,were assessed for bioequivalence based on current guidelines.
- Conditions
- Healthy Volunteers
- Being tested
- test-anastrozole tablet (Salutas Pharma GmbH), reference-anastrozole tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test-anastrozole tablet (Salutas Pharma GmbH)Drug
Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
reference-anastrozole tabletDrug
Also called Arimidex
Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
| Study group | Role | What they receive |
|---|---|---|
| test-anastrozole tablet | Experimental | 1 mg anastrozole was produced and provided by Salutas Pharma GmbH Receives: Drug: test-anastrozole tablet (Salutas Pharma GmbH) |
| reference-anastrozole tablet | Experimental | 1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP. Receives: Drug: reference-anastrozole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ratios of geometrical mean
The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start4 Jul 2020 (estimated)
- Primary completion3 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, doctor, Principal investigator, the study director of phase I clinical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445922
- Sponsor's protocol ID
- TG1915ANA
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition: A Open-label, Randomized,Single- Dose,Two-period, Two-group, Crossover Study
- ClinicalTrials.gov ID
- NCT04445922
- Acronym / sponsor ID
- TG1915ANA
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 4 Jul 2020 (estimated)
- Primary completion
- 3 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 24 Jun 2020 (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.
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fed conditions to assess the bioequivalence between two formulations of Anastrozole.
Detailed description
Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese female subjects were randomized to receive a single dose of 1.0-mg test and reference formulations of anastrozole within 30 min after beginning the consumption of a recommended high-fat, high-calorie breakfast (150 calories from protein, 250 calories from carbohydrate, and 500-600 calories from fat; total calories approximately 800-1000).This was repeated two times, separated by a 21-day washout period.Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1.5, 2, 2h20min, 2h40min, 3, 3.5, 4, 4.5, 5, 7, 12, 24, 48 and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞,were assessed for bioequivalence based on current guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test-anastrozole tablet | Experimental | Drug: test-anastrozole tablet (Salutas Pharma GmbH)1 mg anastrozole was produced and provided by Salutas Pharma GmbH |
| reference-anastrozole tablet | Experimental | Drug: reference-anastrozole tablet1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Postmenopausal volunteers aged between 18 and 65 years old.
- The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
- The subjects have no family planning within 6 months and could select contraceptive method.
- Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.
Key exclusion criteria (6 listed)
- Meet the diagnostic criteria for osteoporosis.
- Subjects with vaginal bleeding.
- blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
- any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
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 |
|---|---|---|
| test-anastrozole tablet (Salutas Pharma GmbH)Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex | Drug | test-anastrozole tablet |
| reference-anastrozole tabletAlso: ArimidexSubjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex | Drug | reference-anastrozole tablet |
Primary outcome
the ratios of geometrical mean
Time frame: 60 days
The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Yu Cao, doctor principal investigator
the study director of phase I clinical research center
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 test-anastrozole tablet (Salutas Pharma GmbH) and reference-anastrozole tablet in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, doctor (86 18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ratios of geometrical mean (time frame: 60 days). 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 30 Jun 2020.