The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers

• Sponsor: Jeil Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03247140
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers

Condition or Disease	Intervention/Treatment	Phase
Hypertension With Dyslipidemia	Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
• Actual Study Start Date: Jun 10, 2017
• Actual Primary Completion Date: Aug 7, 2017
• Actual Study Completion Date: Nov 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I (JLP-1401) JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)	Drug: JLP-1401; Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin); Drug: Telmisartan/Amlodipine, Rosuvastatin; Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
Experimental: Group II(Telmisartan/Amlodipine, Rosuvastatin) Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)	Drug: JLP-1401; Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin); Drug: Telmisartan/Amlodipine, Rosuvastatin; Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Outcome Measures

Primary Outcome Measures

1. AUC [72hr after baseline]

   Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

2. Cmax [72 after baseline]

   Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2

• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial

• Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

• Subjects who are allergic to investigational drug.

• Subjects who have a medical history which can affect the clinical trial.

• Systolic BP > 140mmHG or Diastolic BP > 90mmHg)

• AST or ALT > X 2 UNL

• History of drug abuse or positive drug screening.

• Participation in other drug studies within 3 months prior to the drug administration.

• Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Jeonju		Korea, Republic of

Sponsors and Collaborators

• Jeil Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Min Gul Kim, MD., Ph.D, Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeil Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03247140
• Other Study ID Numbers: JLP-1401-101-PK
• First Posted: Aug 11, 2017
• Last Update Posted: Dec 26, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyslipidemias; Amlodipine; Telmisartan; Telmisartan amlodipine combination; Rosuvastatin Calcium

Study Results

No Results Posted as of Dec 26, 2017