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Pharmacokinetics clinical trials

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NCT ID: NCT00721448 Completed - Pharmacokinetics Clinical Trials

An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This will be a single centre study conducted at the 3rd hospital affiliated to Peking University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited to obtain at least 20 evaluable volunteers. The primary objective of this study is to characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese volunteers. The secondary objective of this study is to determine the safety and tolerability of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events in healthy Chinese volunteers.

NCT ID: NCT00714857 Completed - Pharmacokinetics Clinical Trials

Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Dex-Pop-PK
Start date: October 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (>48 hours) dexmedetomidine infusions in humans. The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.

NCT ID: NCT00714337 Completed - Pharmacokinetics Clinical Trials

Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

Start date: June 2008
Phase: Phase 1
Study type: Interventional

To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

NCT ID: NCT00710606 Completed - Pharmacokinetics Clinical Trials

Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®

Start date: June 2008
Phase: N/A
Study type: Interventional

There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.

NCT ID: NCT00709982 Completed - Healthy Clinical Trials

A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.

Start date: May 2005
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined.

NCT ID: NCT00709644 Completed - Pharmacokinetics Clinical Trials

Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.

Start date: April 2005
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

NCT ID: NCT00709332 Completed - Contraception Clinical Trials

A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.

Start date: January 2005
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of oral contraceptive (OC) [250 mcg NGM/35 mcg EE] tablets.

NCT ID: NCT00709267 Completed - Healthy Clinical Trials

Bioavailability Study of Folic Acid in Healthy Women

Start date: October 2004
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the bioavailability of orally administered folic acid compared with the i.v. administered folic acid, and to use the samples collected to validate the analytical methods for estimation of folic acid in plasma and red blood cells (RBCs).

NCT ID: NCT00709189 Completed - Contraception Clinical Trials

Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.

Start date: May 2005
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

NCT ID: NCT00701636 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

Start date: July 2008
Phase: Phase 3
Study type: Interventional

This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.