Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01526122 |
Recruitment Status :
Completed
First Posted : February 3, 2012
Last Update Posted : October 1, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis | Drug: G0041(75/100mg) Drug: Clopidogrel & Aspirin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: G0041(75/100mg) |
Drug: G0041(75/100mg)
G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO |
Active Comparator: Clopidogrel & Aspirin |
Drug: Clopidogrel & Aspirin
Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO |
- C(max) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
- AUC(last) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
- C(max) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
- AUC(last) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
- C(max) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
- AUC(last) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy male volunteers between the ages of 20 to 50 years old
- weight more than 55kg and within the range of ±20% of IBW
- having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- doctor determines to be suitable as subjects within 3 weeks ago before administration
Exclusion Criteria:
- Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
- Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
- Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣
- Creatinine clearance < 80 mL/min
- Gastrointestinal diseases or surgeries that affect absorption of drug
- Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
- Excessive drinking(exceed 21units/week)
- Smoking over 10 cigarettes per day

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526122
Principal Investigator: | Young-ran Yoon, M.D., Ph.D. | Kyungpook National University Hospital |
Publications:
Responsible Party: | Dong-A ST Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01526122 History of Changes |
Other Study ID Numbers: |
G0041(75/100mg)_AS_Ⅰ |
First Posted: | February 3, 2012 Key Record Dates |
Last Update Posted: | October 1, 2014 |
Last Verified: | September 2014 |
Clopidogrel Aspirin coadministration |
Aspirin Clopidogrel Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |