HypertensionPhase 1NCT04600284

Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

A Phase 1 study testing AD-2101, AD-2102 and AD-2101 + AD-2102 in people with Hypertension, run by Addpharma Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects. Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: AD-2101, AD-2102 and AD-2101 + AD-2102
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteSouth Korea
Study dates: 16 Nov 2020to 30 Apr 2021
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 19 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male between 19 and 50 years of age at the time of screening
Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Who cannot join

Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
A person who has a history of drug abuse
AST, ALT, Total bilirubin values over than 2 times of UNL at screening
Creatinine clearance under 80mL/min

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Korea University Guro Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Read the detailed description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Conditions: Hypertension
Being tested: AD-2101, AD-2102, AD-2101 + AD-2102
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AD-2101Drug
AD-2101 16/5mg
AD-2102Drug
AD-2102 25mg
AD-2101 + AD-2102Drug
AD-2101 16/5mg + AD-2102 25mg

Study groups in NCT04600284
Study group	Role	What they receive
Sequence 1	Experimental	Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102
Sequence 2	Experimental	Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102
Sequence 3	Experimental	Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102
Sequence 4	Experimental	Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102
Sequence 5	Experimental	Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102
Sequence 6	Experimental	Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101 Receives: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration
Cmax,ss of the total ingredient of AD-2101 and AD-2102
Measured: pre-dose to 24 hours
Area under the plasma concentration versus time curve
AUCt,ss of the total ingredient of AD-2101 and AD-2102
Measured: pre-dose to 24 hours

Secondary outcomes (4)

Time to reach Cmax
Tmax,ss of the total ingredient of AD-2101 and AD-2102
Measured: pre-dose to 24 hours
Clearance
CLss/F of the total ingredient of AD-2101 and AD-2102
Measured: pre-dose to 24 hours
Bottom Plasma Concentration
Cmin,ss of the total ingredient of AD-2101 and AD-2102
Measured: pre-dose to 24 hours
Number of participants with adverse events
Incidence rate of adverse events
Measured: From Day 1 up to Day 66

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202030 Apr 2021

First posted23 Oct 2020
Study start16 Nov 2020
Primary completion20 Jan 2021
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04600284
Sponsor's protocol ID: AD-210DDI
Status last verified: Jul 2021
First submitted: 19 Oct 2020
Last updated: 21 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04600284
Acronym / sponsor ID: AD-210DDI
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Addpharma Inc.Industry (pharma, biotech, devices)
Study start: 16 Nov 2020 (actual)
Primary completion: 20 Jan 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 23 Oct 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.

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Detailed description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Sequence 2	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Sequence 3	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Sequence 4	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Sequence 5	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Sequence 6	Experimental	Drug: AD-2101, Drug: AD-2102, Drug: AD-2101 + AD-2102Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male between 19 and 50 years of age at the time of screening
Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Key exclusion criteria (5 listed)

Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
A person who has a history of drug abuse
AST, ALT, Total bilirubin values over than 2 times of UNL at screening
Creatinine clearance under 80mL/min

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
AD-2101AD-2101 16/5mg	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
AD-2102AD-2102 25mg	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
AD-2101 + AD-2102AD-2101 16/5mg + AD-2102 25mg	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Peak Plasma Concentration
Time frame: pre-dose to 24 hours
Cmax,ss of the total ingredient of AD-2101 and AD-2102
Area under the plasma concentration versus time curve
Time frame: pre-dose to 24 hours
AUCt,ss of the total ingredient of AD-2101 and AD-2102

4 secondary outcomes

Time to reach Cmax
Time frame: pre-dose to 24 hours
Clearance
Time frame: pre-dose to 24 hours
Bottom Plasma Concentration
Time frame: pre-dose to 24 hours
Number of participants with adverse events
Time frame: From Day 1 up to Day 66

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 21 Jul 2021.

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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.

HyeWon Chung principal investigator

Korea University Guro Hospital

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 AD-2101, AD-2102 and AD-2101 + AD-2102 in people with Hypertension, run by Addpharma Inc. at 1 site in South Korea.

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 2 inclusion and 5 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 21 Jul 2021. 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 South Korea. 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?

Peak Plasma Concentration (time frame: pre-dose to 24 hours). 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?

On the ClinicalTrials.gov record for NCT04600284.

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 21 Jul 2021.