PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
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| ClinicalTrials.gov Identifier: NCT01975961 |
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Recruitment Status :
Completed
First Posted : November 5, 2013
Last Update Posted : November 5, 2013
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This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyslipidemia & Hypertension | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 185 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Official Title: | A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FDC YH16410
Drug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg). Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state |
Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet. |
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Active Comparator: Co-administration
Drug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg). Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose |
Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet. |
- plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments [ Time Frame: 0~72hr, 17points ]
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| Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects
Exclusion Criteria:
- History of and clinically significant disease
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥ Heart rate ≤ 40
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- Administration of other investigational products within 90 days prior to the first dosing.
- Administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
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): NCT01975961
| Korea, Republic of | |
| Severance Hospital | |
| Seoul, Korea, Republic of | |
| Responsible Party: | Yuhan Corporation |
| ClinicalTrials.gov Identifier: | NCT01975961 |
| Other Study ID Numbers: |
YH16410-102 |
| First Posted: | November 5, 2013 Key Record Dates |
| Last Update Posted: | November 5, 2013 |
| Last Verified: | October 2013 |
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Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Telmisartan Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |