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Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atazanavir

Intervention: atazanavir (Drug); Atazanavir(ATZ) and Tenofovir(TDF) (Drug); Atazanavir(ATZ) + Ritonavir (Drug); atazanavir(ATZ) + tenofovir(TDF) + ritonavir (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Asan Medical Center

Overall contact:
Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622

Summary

Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.

Clinical Details

Official title: Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Pharmacokinetic analysis

Secondary outcome: Pharmacokinetic evaluation

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men aged 20 to 55 years old, with a weight more than 50 kg and with appropriate body

mass index (BMI) values within 19-28 kg/m2.

- Agreed voluntarily to participate to the study and comply with the study protocol

with written permission. Exclusion Criteria:

- Has history of liver, kidney, respiratory, musculoskeletal, endocrinologic,

neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).

- Has history of hypersensitivity or clinically significant adverse drug reaction(s) to

the study drugs, same class of the study drugs, or other drugs including aspirin and antibiotics.

- Drinks excessive caffeinated beverages (caffeine >10 units/day), alcohol beverages

(alcohol >21 units/week) or smokes excessively (>20 cigarettes/day) or has history of alcoholism.

- Has been excluded by the researchers due to abnormal findings in screening EKG and/or

blood tests

Locations and Contacts

Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622

Asan Medical Center, Songpa-gu, Seoul 138-736, Korea, Republic of; Not yet recruiting
Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622
Additional Information

Starting date: June 2011
Last updated: June 7, 2011

Page last updated: August 23, 2015

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