Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects

Healthy Male Subjects Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02614352
• Other study ID #: AGCA_BE_1501
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 24, 2015
• Last updated: November 24, 2015

Study information

• Verified date: November 2015
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: JINHYUNG KIM
• Email: agpp[@]ahn-gook.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: February 2016
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Adult healthy males 19 to 45 years at screening.

• BMI 18-29 kg/m2

Exclusion Criteria:

• History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease

• Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin

• Hypotension (DBP = 100 mmHg or SBP = 95mmHg) and hypertension (SBP = 150 mmHg or DBP = 95 mmHg)

• Gastrointestinal disease affected the absorption of medications

• Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

• AST or ALT > 2 x normal range

• Total bilirubin > 2.0 mg/dl

• CK > 2 x normal range

• eGFR < 60 mL/min/1.73m2

• Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study

• Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study

• Subject who treated with any investigational drugs within 90 days before the administration of investigational drug

• Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days

• Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin

• Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days

• History of drug abuse

• Genetic neuromuscular disorder or family history of neuromuscular disorder

• Unusual diet affected the absorption, distribution, metabolism, excretion of medications

• Subjects deemed ineligible by investigator based on other reasons

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• Atorvastatin + Candesartan

• AG1502

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (candesartan cilexetil)		0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours	No
Primary	AUClast (candesartan cilexetil)		0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours	No
Primary	Cmax (Atorvastatin)		0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours	No
Primary	AUClast (Atorvastatin)		0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours	No