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

• Sponsor: Addpharma Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04600284
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 6
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 16, 2020
• Actual Primary Completion Date: Jan 20, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 2 Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 3 Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 4 Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 5 Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg
Experimental: Sequence 6 Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101	Drug: AD-2101; AD-2101 16/5mg; Drug: AD-2102; AD-2102 25mg; Drug: AD-2101 + AD-2102; AD-2101 16/5mg + AD-2102 25mg

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration [pre-dose to 24 hours]

   Cmax,ss of the total ingredient of AD-2101 and AD-2102

2. Area under the plasma concentration versus time curve [pre-dose to 24 hours]

   AUCt,ss of the total ingredient of AD-2101 and AD-2102

Secondary Outcome Measures

1. Time to reach Cmax [pre-dose to 24 hours]

   Tmax,ss of the total ingredient of AD-2101 and AD-2102

2. Clearance [pre-dose to 24 hours]

   CLss/F of the total ingredient of AD-2101 and AD-2102

3. Bottom Plasma Concentration [pre-dose to 24 hours]

   Cmin,ss of the total ingredient of AD-2101 and AD-2102

4. Number of participants with adverse events [From Day 1 up to Day 66]

   Incidence rate of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Addpharma Inc.

Investigators

• Principal Investigator: HyeWon Chung, Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addpharma Inc.
• ClinicalTrials.gov Identifier: NCT04600284
• Other Study ID Numbers: AD-210DDI
• First Posted: Oct 23, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 21, 2021