Drug-drug-interaction Study of Candesartan, Amlodipine and Atorvastatin

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245046
• Other study ID #: CAAMAT-T1018/71
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2019
• Est. completion date: February 18, 2019

Study information

• Verified date: January 2020
• Source: Midas Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Candesartan, Amlodipine, Atorvastatin
compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose

Locations

Country	Name	City	State
Jordan	International Pharmaceutical Research Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Midas Pharma GmbH

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma concentration at steady state (Cmaxss)	Maximum plasma concentration, it is read directly from the raw data	up to 24 hours post-administration at steady state
Primary	Area under the Plasma concentration curve (AUC0-t)	Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)	up to 24 hours post-administration at steady state
Secondary	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.	complete study, Day 1 until Day 31 (Follow-up)
Secondary	Time until Cmaxss is reached (tmaxss)	Time until Cmax is reached, it is read directly from the observed concentrations	up to 24 hours post-administration at steady state