Healthy VolunteersPhase 1NCT04245046
Drug-drug-interaction Study of Candesartan, Amlodipine and Atorvastatin
A Phase 1 study testing Candesartan, Amlodipine, Atorvastatin in people with Healthy Volunteers, run by Midas Pharma GmbH at 1 site in Jordan.
Trial summary
Study to determine the potential pharmacokinetic interaction of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. 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
- Healthy Volunteers
- What is being tested?
- Candesartan, Amlodipine, Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJordan
- Study dates
- 18 Jan 2019to 18 Feb 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male Caucasian, aged 18 to 50 years, inclusive.
- Body Mass Index (BMI) range within 18.5 - 30.0 Kg/m2.
- Physically and mentally healthy as judged by means of medical and standard laboratory examinations. Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- Standard ECG assessment is normal
- Informed consent given in written form according to chapter 5.3 of the study protocol.
Who cannot join
- Known allergy to the drugs under investigation or any ingredients or any other related drugs.
- Participation in a relative bioavailability study or in a clinical study within the last 80 days before first study drug administration or blood donation
- Presence of any clinically significant results from laboratory tests, vital sign assessment and electrocardiogram as judged by the investigator. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- Results of CPK or liver or kidney function tests which are outside the reference range.
- Hb test lower than 13.3 g/dl.
- Positive serologic findings
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- History of drug or alcohol abuse.
- Subject is a heavy smoker.
- Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
- Subject having at screening examination a sitting blood pressure of less than 110/70 mm Hg or more than or equal to 140/90 mm Hg.
- Subjects who are known or suspected: not to comply with the study directives, not to be reliable or trustworthy, not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed, to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Candesartan, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration
Study to determine the potential pharmacokinetic interaction of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. This study aims to determine if the steady state study pharmacokinetic parameters of any of the given drugs and the tolerability is altered when administered concomitantly.
Read the detailed description
This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial to compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the absence and presence of each other.
Bioanalysis of candesartan, atorvastatin and amlodipine is performed by LC/MS/MS method.
- Conditions
- Healthy Volunteers
- Being tested
- Candesartan, Amlodipine, Atorvastatin
- Keywords
- Candesartan, Amlodipine, Atorvastatin, drug interaction, multiple-dose, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan, Amlodipine, AtorvastatinDrug
compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-B-C-ABC | Experimental | The demographic characteristics of the 18 male subjects were as follows:
* Age: 18-49 years
* Weight: 55-105 kg
* Height: 163-188 cm
* BMI 18.5-29.9 kg/m² Receives: Drug: Candesartan, Amlodipine, Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma concentration at steady state (Cmaxss)
Maximum plasma concentration, it is read directly from the raw data
Measured: up to 24 hours post-administration at steady state
Area under the Plasma concentration curve (AUC0-t)
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
Measured: up to 24 hours post-administration at steady state
Secondary outcomes (2)
Safety measurement (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: complete study, Day 1 until Day 31 (Follow-up)
Time until Cmaxss is reached (tmaxss)
Time until Cmax is reached, it is read directly from the observed concentrations
Measured: up to 24 hours post-administration at steady state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start18 Jan 2019
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects are to be admitted the night before dose no. 1 administration, confining at clinical site until the 24 hours post dose no. 5 administration. 4-days off interval between last dose of treatment A and first dose of treatment B allowed. Subjects to be admitted the night before dose no. 6 administration, confining at clinical site until the 24 hours post dose no. 10 administration. 4-days off interval between last dose of treatment B and first dose of treatment C allowed. Subjects to be admitted the night before dose no. 11 administration, confining at clinical site until the 24 hours post dose no. 26 administration.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midas Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed Bader, Study director, International Pharmaceutical Research Center, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245046
- Sponsor's protocol ID
- CAAMAT-T1018/71
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 5 Feb 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Candesartan, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration
- ClinicalTrials.gov ID
- NCT04245046
- Acronym / sponsor ID
- CAAMAT-T1018/71
- Conditions
- Healthy Volunteers
- Keywords
- Candesartan, Amlodipine, Atorvastatin, drug interaction, multiple-dose, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Midas Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 28 Jan 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.
Study to determine the potential pharmacokinetic interaction of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. This study aims to determine if the steady state study pharmacokinetic parameters of any of the given drugs and the tolerability is altered when administered concomitantly.
Detailed description
This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial to compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the absence and presence of each other.
Bioanalysis of candesartan, atorvastatin and amlodipine is performed by LC/MS/MS method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects are to be admitted the night before dose no. 1 administration, confining at clinical site until the 24 hours post dose no. 5 administration. 4-days off interval between last dose of treatment A and first dose of treatment B allowed. Subjects to be admitted the night before dose no. 6 administration, confining at clinical site until the 24 hours post dose no. 10 administration. 4-days off interval between last dose of treatment B and first dose of treatment C allowed. Subjects to be admitted the night before dose no. 11 administration, confining at clinical site until the 24 hours post dose no. 26 administration.
| Arm | Type | Receives |
|---|---|---|
| Treatment A-B-C-ABC | Experimental | Drug: Candesartan, Amlodipine, AtorvastatinThe demographic characteristics of the 18 male subjects were as follows: * Age: 18-49 years * Weight: 55-105 kg * Height: 163-188 cm * BMI 18.5-29.9 kg/m² |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male Caucasian, aged 18 to 50 years, inclusive.
- Body Mass Index (BMI) range within 18.5 - 30.0 Kg/m2.
- Physically and mentally healthy as judged by means of medical and standard laboratory examinations. Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- Standard ECG assessment is normal
- Informed consent given in written form according to chapter 5.3 of the study protocol.
Key exclusion criteria (11 listed)
- Known allergy to the drugs under investigation or any ingredients or any other related drugs.
- Participation in a relative bioavailability study or in a clinical study within the last 80 days before first study drug administration or blood donation
- Presence of any clinically significant results from laboratory tests, vital sign assessment and electrocardiogram as judged by the investigator. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- Results of CPK or liver or kidney function tests which are outside the reference range.
- Hb test lower than 13.3 g/dl.
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 |
|---|---|---|
| Candesartan, Amlodipine, Atorvastatincompare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose | Drug | Treatment A-B-C-ABC |
Primary outcome
Maximum Plasma concentration at steady state (Cmaxss)
Time frame: up to 24 hours post-administration at steady state
Maximum plasma concentration, it is read directly from the raw data
Area under the Plasma concentration curve (AUC0-t)
Time frame: up to 24 hours post-administration at steady state
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
2 secondary outcomes
Safety measurement (Adverse Events)
Time frame: complete study, Day 1 until Day 31 (Follow-up)
Time until Cmaxss is reached (tmaxss)
Time frame: up to 24 hours post-administration at steady state
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Mohammed Bader study director
International Pharmaceutical Research Center, Jordan
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 Candesartan, Amlodipine, Atorvastatin in people with Healthy Volunteers, run by Midas Pharma GmbH at 1 site in Jordan.
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 11 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 5 Feb 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 Jordan. 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?
Maximum Plasma concentration at steady state (Cmaxss) (time frame: up to 24 hours post-administration at steady state). 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 5 Feb 2020.