Biological AvailabilityBEADNCT03886766
Bioavailability Mechanistic Study of Hot-Melt Extruded Amorphous Solid Dispersions
A study testing Hot-melt extruded amorphous solid dispersion of Efavirenz, Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles and Efavirenz solution in people with Biological Availability and Amorphous Solid Dispersions, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability, Amorphous Solid Dispersions
- What is being tested?
- Hot-melt extruded amorphous solid dispersion of Efavirenz, Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles and Efavirenz solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2019to 19 Mar 2020
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full mental and legal capacity, ability and willingness to understand and comply to study interventions and restrictions and to communicate with study personnel.
- Informed Consent, documented by signature (Informed Consent Form).
- Physically and mentally healthy male participants, age of 18 to 50 years.
- Body mass index (BMI) of 18.0 to 29.9 kg/m2, systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50- 90 mmHg and heart rate (HR) 45-90 bpm, measured on the leading arm, after 5 minutes in supine position, Hemoglobin ≥ 11 g/dl at screening.
- Normal physical examination, vital signs, laboratory workup (clinical chemistry and hematology), and electrocardiogram (ECG) (in opinion of the principal investigator).
- Normal renal and liver function based on blood tests (in opinion of the investigator).
- Medical history that is in line with the eligibility criteria. (in opinion of the investigator).
- No other conditions or circumstances that might compromise compliance with the study protocol or the quality of retrieved data (in opinion of the investigator).
Who cannot join
- Any acute or chronic illness or other clinically relevant findings at screening.
- Any physical or mental disorder or circumstance at present or in medical history that could interfere with the participant's safety during the clinical trial or with the study objectives.
- Any regular drug treatment within the last two weeks or planned for the time of the study (exceptions possible in opinion of the investigator).
- At presence of irregular drug treatment before the study, planned for the time of the study or irregular/regular substitution of endogenous substances, minerals, or trace elements, the investigator decides on exclusion on an individual basis valuing the safety of the participant and the quality of retrieved data (e.g. interactions with Efavirenz). For minor to moderate painful conditions, such as headaches or abdominal discomfort, paracetamol up to 1 g every 6 hours is acceptable.
- Any intake of a substance known to induce or inhibit drug metabolizing enzymes or transport system enzymes relevant for Efavirenz (CYP 2B6 and CYP 3A4) within a period of less than 10 times the respective elimination half-life.
- Vaccination (active or passive) ≤ one month before screening.
Show all 16Show fewer
- Presence or history of allergies (except for mild forms of hay fever).
- History of hypersensitivity reactions to medication.
- History or presence of eating disorders.
- Presence of contraindications to treatment with Efavirenz, namely less than 40 kg body weight, co-medication with voriconazole, paritaprevir, ritonavir, dasabuvir, simeprevir, and hypericum perforatum.any co-medication (also plant products), or any liver disease.
- Presence of warnings concerning the treatment with Efavirenz, namely severe skin irritations in the medical history, psychiatric symptoms in the medical history, convulsions in the medical history, hepatitis B or C, presence of osteonecrosis in the medical history, or dyslipidemia at present or in medical history.
- History or presence of smoking, alcohol drinking (>20 g alcohol per day), or drug abuse.
- Blood donation or significant blood loss within 4 weeks prior to screening
- Known or suspected non-compliance
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pharmaceutical Technology, University of Basel, Pharmazentrum
Basel, 4056
About this study
Official title: Bioavailability Mechanistic Study of Hot-Melt-Extruded Amorphous Solid Dispersions
It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances.
Read the detailed description
Poor drug solubility, and therefore low bioavailability, remains a problem in drug development that causes many drug candidates to drop out during drug development. Bioavailability is linked to drug solubility and intestinal permeability. A promising method to increase drug solubility, and therefore bioavailability, is the formulation of the drug as hot-melt extruded amorphous solid dispersion drug delivery systems, which have been shown to potentially increase in vivo and clinical bioavailability.The mechanisms that lead to increased bioavailability are not understood completely.
In this study, investigators investigate the role of amorphous solid dispersions and thereof generated drug-rich particles on bioavailability and their in vivo behaviour. Investigators do so by administering the delivery system at different stages in the process of drug availability.
Primary objectives are the pharmacokinetic analysis of a model formulation using efavirenz as model drug tracer in human.
- Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities.
- Mechanistic analysis of pharmacokinetic data, such as determination of in vivo dissolution from the solid formulation (study product 1) to drug rich particles (study product 2) using numerical deconvolution or analysis of the effect of drug rich particles on the absorption rate of Efavirenz in comparison to the solution of Efavirenz (study product 3).
Secondary objectives are the comparison of obtained pharmacokinetic profiles to existing data of a conventional formulation with respect to:
- Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities.
- Extrapolation investigation from in vitro to in vivo data.
Safety objectives are the recording of any side effects or tolerability issues of the investigational drug delivery system.
- Being tested
- Hot-melt extruded amorphous solid dispersion of Efavirenz, Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles, Efavirenz solution
- Keywords
- amorphous solid dispersion, Plasma concentration-time profile, Hot-Melt Extrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot-melt extruded amorphous solid dispersion of EfavirenzDrug
Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1)
Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particlesDrug
Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2)
Efavirenz solutionDrug
Efavirenz solution, 3 mg, oral administration (product 3)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1,2,3 | Experimental | Period A/ Visit 2: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) Period B/ Visit 6: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) Period C/ Visit 10: Efavirenz solution, 3 mg, oral administration (product 3) Receives: Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz; Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles; Drug: Efavirenz solution |
| Sequence 2,3,1 | Experimental | Period A/ Visit 2: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) Period B/ Visit 6: Efavirenz solution, 3 mg, oral administration (product 3) Period C/ Visit 10: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) Receives: Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz; Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles; Drug: Efavirenz solution |
| Sequence 3,1,2 | Experimental | Period A/ Visit 2: Efavirenz solution, 3 mg, oral administration (product 3) Period B/ Visit 6: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) Period C/ Visit 10: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) Receives: Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz; Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles; Drug: Efavirenz solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the curve in plasma concentration - time profiles of efavirenz after administration of the different study products.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Relative bioavailability
Ratio between areas under the curve.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Cmax
Maximal concentration in the plasma concentration - time profiles of efavirenz after administration of the different study products.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Tmax
Time of maximal concentration in the plasma concentration - time profiles of efavirenz after administration of the different study products.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
ka
Absorption rate constant from the concentration in the Plasma concentration - time profiles of efavirenz after administration of the different study products.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
In vivo dissolution
Calculation of in vivo dissolution of based on the numerical deconvolution of plasma concentration - time profiles of efavirenz after administration of the different study products.
Measured: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Secondary outcomes (1)
Number of adverse drug reactions
Incidence and severity (CTCAE Version 5) of adverse reactions (adverse event suspected to be related to investigational drug deliver system, expected or not expected) during the whole study.
Measured: During inclusion into study (36 to 54 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start30 Apr 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
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 Biological AvailabilityStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention consists of a single oral administration of 3 different formulations containing Efavirenz as model drug tracer in sub-therapeutic doses: 1. Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) 2. Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) 3. Efavirenz solution, 3 mg, oral administration (product 3) On the first visit, subjects will be randomized into three groups, starting with the ingestion of study product 1, 2, or 3 with subsequent collection of blood samples for 72 hours. After a wash out period of two weeks, participants will repeat the procedure in phase B with ingestion of the subsequent study product. After a second wash out the participants will receive the last study product in study phase C.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Stephan Krähenbühl, Prof. Dr., Principal investigator, University of Basel, Department Biomedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886766
- Sponsor's protocol ID
- 2019-00282; ex18Huwyler
- Other IDs
- 2019
- Acronym
- BEAD
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2019
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schittny A, Waldner S, Duthaler U, Vorobyev A, Abramovich R, Krahenbuhl S, Puchkov M, Huwyler J. Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans. Pharmaceutics. 2021 Mar 17;13(3):401. doi: 10.3390/pharmaceutics13030401.
PubMed 33803049
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Mechanistic Study of Hot-Melt-Extruded Amorphous Solid Dispersions
- ClinicalTrials.gov ID
- NCT03886766
- Acronym / sponsor ID
- BEAD / 2019-00282; ex18Huwyler
- Keywords
- amorphous solid dispersion, Plasma concentration-time profile, Hot-Melt Extrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 22 Mar 2019 (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.
It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances.
Detailed description
Poor drug solubility, and therefore low bioavailability, remains a problem in drug development that causes many drug candidates to drop out during drug development. Bioavailability is linked to drug solubility and intestinal permeability. A promising method to increase drug solubility, and therefore bioavailability, is the formulation of the drug as hot-melt extruded amorphous solid dispersion drug delivery systems, which have been shown to potentially increase in vivo and clinical bioavailability.The mechanisms that lead to increased bioavailability are not understood completely.
In this study, investigators investigate the role of amorphous solid dispersions and thereof generated drug-rich particles on bioavailability and their in vivo behaviour. Investigators do so by administering the delivery system at different stages in the process of drug availability.
Primary objectives are the pharmacokinetic analysis of a model formulation using efavirenz as model drug tracer in human.
- Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities.
- Mechanistic analysis of pharmacokinetic data, such as determination of in vivo dissolution from the solid formulation (study product 1) to drug rich particles (study product 2) using numerical deconvolution or analysis of the effect of drug rich particles on the absorption rate of Efavirenz in comparison to the solution of Efavirenz (study product 3).
Secondary objectives are the comparison of obtained pharmacokinetic profiles to existing data of a conventional formulation with respect to:
- Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities.
- Extrapolation investigation from in vitro to in vivo data.
Safety objectives are the recording of any side effects or tolerability issues of the investigational drug delivery system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention consists of a single oral administration of 3 different formulations containing Efavirenz as model drug tracer in sub-therapeutic doses: 1. Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) 2. Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) 3. Efavirenz solution, 3 mg, oral administration (product 3) On the first visit, subjects will be randomized into three groups, starting with the ingestion of study product 1, 2, or 3 with subsequent collection of blood samples for 72 hours. After a wash out period of two weeks, participants will repeat the procedure in phase B with ingestion of the subsequent study product. After a second wash out the participants will receive the last study product in study phase C.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1,2,3 | Experimental | Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz, Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles, Drug: Efavirenz solutionPeriod A/ Visit 2: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) Period B/ Visit 6: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) Period C/ Visit 10: Efavirenz solution, 3 mg, oral administration (product 3) |
| Sequence 2,3,1 | Experimental | Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz, Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles, Drug: Efavirenz solutionPeriod A/ Visit 2: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) Period B/ Visit 6: Efavirenz solution, 3 mg, oral administration (product 3) Period C/ Visit 10: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) |
| Sequence 3,1,2 | Experimental | Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz, Drug: Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles, Drug: Efavirenz solutionPeriod A/ Visit 2: Efavirenz solution, 3 mg, oral administration (product 3) Period B/ Visit 6: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) Period C/ Visit 10: Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Full mental and legal capacity, ability and willingness to understand and comply to study interventions and restrictions and to communicate with study personnel.
- Informed Consent, documented by signature (Informed Consent Form).
- Physically and mentally healthy male participants, age of 18 to 50 years.
- Body mass index (BMI) of 18.0 to 29.9 kg/m2, systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50- 90 mmHg and heart rate (HR) 45-90 bpm, measured on the leading arm, after 5 minutes in supine position, Hemoglobin ≥ 11 g/dl at screening.
- Normal physical examination, vital signs, laboratory workup (clinical chemistry and hematology), and electrocardiogram (ECG) (in opinion of the principal investigator).
Key exclusion criteria (16 listed)
- Any acute or chronic illness or other clinically relevant findings at screening.
- Any physical or mental disorder or circumstance at present or in medical history that could interfere with the participant's safety during the clinical trial or with the study objectives.
- Any regular drug treatment within the last two weeks or planned for the time of the study (exceptions possible in opinion of the investigator).
- At presence of irregular drug treatment before the study, planned for the time of the study or irregular/regular substitution of endogenous substances, minerals, or trace elements, the investigator decides on exclusion on an individual basis valuing the safety of the participant and the quality of retrieved data (e.g. interactions with Efavirenz). For minor to moderate painful conditions, such as headaches or abdominal discomfort, paracetamol up to 1 g every 6 hours is acceptable.
- Any intake of a substance known to induce or inhibit drug metabolizing enzymes or transport system enzymes relevant for Efavirenz (CYP 2B6 and CYP 3A4) within a period of less than 10 times the respective elimination half-life.
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 |
|---|---|---|
| Hot-melt extruded amorphous solid dispersion of EfavirenzHot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1) | Drug | Sequence 1,2,3, Sequence 2,3,1, Sequence 3,1,2 |
| Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particlesHot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2) | Drug | Sequence 1,2,3, Sequence 2,3,1, Sequence 3,1,2 |
| Efavirenz solutionEfavirenz solution, 3 mg, oral administration (product 3) | Drug | Sequence 1,2,3, Sequence 2,3,1, Sequence 3,1,2 |
Primary outcome
AUC
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Area under the curve in plasma concentration - time profiles of efavirenz after administration of the different study products.
Relative bioavailability
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Ratio between areas under the curve.
Cmax
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Maximal concentration in the plasma concentration - time profiles of efavirenz after administration of the different study products.
Tmax
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Time of maximal concentration in the plasma concentration - time profiles of efavirenz after administration of the different study products.
ka
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Absorption rate constant from the concentration in the Plasma concentration - time profiles of efavirenz after administration of the different study products.
In vivo dissolution
Time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing
Calculation of in vivo dissolution of based on the numerical deconvolution of plasma concentration - time profiles of efavirenz after administration of the different study products.
1 secondary outcome
Number of adverse drug reactions
Time frame: During inclusion into study (36 to 54 days)
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 20 Dec 2024.
- Results publication: PubMed 33803049Schittny A, Waldner S, Duthaler U, Vorobyev A, Abramovich R, Krahenbuhl S, Puchkov M, Huwyler J. Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans. Pharmaceutics. 2021 Mar 17;13(3):401. doi: 10.3390/pharmaceutics13030401.
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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.
Stephan Krähenbühl, Prof. Dr. principal investigator
University of Basel, Department Biomedicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot-melt extruded amorphous solid dispersion of Efavirenz, Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles and Efavirenz solution in people with Biological Availability and Amorphous Solid Dispersions, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 16 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 20 Dec 2024. 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 Switzerland. 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.
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?
AUC (time frame: before dosing and at time points 15 minutes, 30 minutes, 45 minutes, 60 minutes, followed by sampling at 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, and 72 hours after dosing). The study lists 6 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 NCT03886766, 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 20 Dec 2024.