Normal Healthy SubjectsPhase 1NCT01652859
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
A Phase 1 study testing Liposomal Amphotericin B and AmBisome in people with Normal Healthy Subjects, run by Taiwan Liposome Company.
Trial summary
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Subjects
- What is being tested?
- Liposomal Amphotericin B and AmBisome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2012
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be adults (> 20 years old) in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm
- Fasting blood glucose < 100 mg/dL.
- Body weight must be above 50 kg for men and 45 kg for women and within 20% of ideal body weight.
- Negative urine drug screen at clinic check-in before each dosing
- Able to sign informed consent prior to study.
- Able to communicate well with the investigator and comply with the requirements of the study.
- Pregnancy tests (female only): negative reaction
Who cannot join
- Use of any prescription or over the counter medication within 14 days prior to investigational products administration; with the exception of acetaminophen (not more than 2 g/day) or vitamins.
- A plan to take concomitant medications while enrolled in the study, with the exception of acetaminophen (not more than 2 g/day) or vitamins.
- Presence of any acute or chronic medical condition within 2 weeks prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. Evidence of impaired renal function as indicated by clinically significant abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria) as judged by the investigator. Evidence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an clinically significant abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBs Ag, or HCV Ab as judged by the investigator.
- Hemoglobin less than 12 g/dL
- Participation in any clinical investigation within 2 months or 5 half-lives, whichever is longer, prior to investigational products administration.
- Donation or loss of more than 500 mL blood within 3 months prior to investigational products administration.
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- Subject is known for HIV infected.
- Known allergy or hypersensitivity to amphotericin B or its analogs.
- History of drug or alcohol abuse within 12 months prior to investigational products administration ; current consumption of alcohol in excess of 28 units/week (one unit is 6 oz of beer, ½ oz of hard liquor, or 2 oz of wine)
- Subjects who, in the opinion of the investigator, should not participate in the study or may not be capable of following the study schedule for any reason.
- Consumption of more than 36 to 40 oz (1.1-1.2 L) of caffeine-containing beverages per day
- Consumption of any products containing grapefruit in the 3 days before clinic check-in.
About this study
Official title: An Open-label, Randomized, Balanced, Crossover Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.
- Conditions
- Normal Healthy Subjects
- Being tested
- Liposomal Amphotericin B, AmBisome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Amphotericin BDrug
AmBisomeDrug
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Amphotericin B | Experimental | Generic drug Receives: Drug: Liposomal Amphotericin B |
| AmBisome | Active comparator | RLD Receives: Drug: AmBisome |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bioequivalence of two different liposomal amphotericin B injections
90% CI of Cmax and AUCinf of Liposomal and non-liposomal Amphotericin B between Ambil and AmBisome within 80.00%~125.00%.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Normal Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652859
- Sponsor's protocol ID
- TLC166.2
- Status last verified
- Nov 2013
- First submitted
- 20 Jul 2012
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Adler-Moore JP, Gangneux JP, Pappas PG. Comparison between liposomal formulations of amphotericin B. Med Mycol. 2016 Mar;54(3):223-31. doi: 10.1093/mmy/myv111. Epub 2016 Jan 14.
PubMed 26768369
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Balanced, Crossover Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01652859
- Acronym / sponsor ID
- TLC166.2
- Conditions
- Normal Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jul 2012 (estimated)
- 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.
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Amphotericin B | Experimental | Drug: Liposomal Amphotericin BGeneric drug |
| AmBisome | Active comparator | Drug: AmBisomeRLD |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must be adults (> 20 years old) in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm
- Fasting blood glucose < 100 mg/dL.
- Body weight must be above 50 kg for men and 45 kg for women and within 20% of ideal body weight.
- Negative urine drug screen at clinic check-in before each dosing
Key exclusion criteria (12 listed)
- Use of any prescription or over the counter medication within 14 days prior to investigational products administration; with the exception of acetaminophen (not more than 2 g/day) or vitamins.
- A plan to take concomitant medications while enrolled in the study, with the exception of acetaminophen (not more than 2 g/day) or vitamins.
- Presence of any acute or chronic medical condition within 2 weeks prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. Evidence of impaired renal function as indicated by clinically significant abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria) as judged by the investigator. Evidence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an clinically significant abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBs Ag, or HCV Ab as judged by the investigator.
- Hemoglobin less than 12 g/dL
- Participation in any clinical investigation within 2 months or 5 half-lives, whichever is longer, prior to investigational products administration.
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 |
|---|---|---|
| Liposomal Amphotericin B | Drug | Liposomal Amphotericin B |
| AmBisome | Drug | AmBisome |
Primary outcome
The bioequivalence of two different liposomal amphotericin B injections
Time frame: 14 days
90% CI of Cmax and AUCinf of Liposomal and non-liposomal Amphotericin B between Ambil and AmBisome within 80.00%~125.00%.
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 27 Nov 2013.
- Derived from this study: PubMed 26768369Adler-Moore JP, Gangneux JP, Pappas PG. Comparison between liposomal formulations of amphotericin B. Med Mycol. 2016 Mar;54(3):223-31. doi: 10.1093/mmy/myv111. Epub 2016 Jan 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Amphotericin B and AmBisome in people with Normal Healthy Subjects, run by Taiwan Liposome Company.
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 8 inclusion and 12 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The bioequivalence of two different liposomal amphotericin B injections (time frame: 14 days). 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 NCT01652859, 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 27 Nov 2013.