Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

NCT ID: NCT04856969

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2021-05-04

Brief Summary

To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.

Detailed Description

• Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state.
• Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.

Conditions

Healthy Adult Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days

Group Type: ACTIVE_COMPARATOR

Olmesartan

Intervention Type: DRUG

First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Dapagliflozin

Intervention Type: DRUG

First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Arm B

ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days

Group Type: ACTIVE_COMPARATOR

Olmesartan

Intervention Type: DRUG

First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Dapagliflozin

Intervention Type: DRUG

First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Interventions

Olmesartan

First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Intervention Type: DRUG

Dapagliflozin

First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Intervention Type: DRUG

Other Intervention Names

brand name: Olmetec; brand name: Forxiga

Eligibility Criteria

Inclusion Criteria

1. Those who are over 19 years old at the screening visit

2. Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit

3. Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit

4. Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.

Exclusion Criteria

• 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.

2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Autotelicbio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KyungWan Nam, Pharm. D.

Role: PRINCIPAL_INVESTIGATOR

Autotelic.bio

Locations

H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Countries

South Korea

Other Identifiers

ATB-101-001

Identifier Type: -

Identifier Source: org_study_id