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NCT ID: NCT03947970 Active, not recruiting - Healthy Clinical Trials

Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the pharmacokinetics of radiolabeled [14C] CR845 administered as a single IV bolus in patients on HD and in healthy subjects.

NCT ID: NCT03947528 Active, not recruiting - Healthy Clinical Trials

Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Sarpogrelate
Start date: March 4, 2019
Phase: Phase 1
Study type: Interventional

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

NCT ID: NCT03892616 Active, not recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood

Start date: April 8, 2019
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2) under fasted conditions compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following oral administration and to investigate the effect of food on the exposure with TF2.

NCT ID: NCT03889366 Active, not recruiting - Healthy Clinical Trials

Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This study will compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state.

NCT ID: NCT03886272 Active, not recruiting - Healthy Clinical Trials

A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood

Start date: April 11, 2019
Phase: Phase 1
Study type: Interventional

The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI 730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1 (Reference, R). The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF batch of BI 730357 with regularly milled API (Reference, R).

NCT ID: NCT03880136 Active, not recruiting - Healthy Clinical Trials

Food Effect Study of CTP-543 in Healthy Volunteers

Start date: March 25, 2019
Phase: Phase 1
Study type: Interventional

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

NCT ID: NCT03871439 Active, not recruiting - Healthy Clinical Trials

OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

Start date: March 13, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.

NCT ID: NCT03848416 Active, not recruiting - Healthy Clinical Trials

A Study of Ixekizumab in Healthy Participants

Start date: January 29, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.

NCT ID: NCT03847207 Active, not recruiting - Healthy Clinical Trials

A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310

Start date: February 13, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1, first in human, three-part, single centre study to assess the safety, tolerability, PK and PD of single ascending subcutaneous doses of HTL0030310 in healthy subjects

NCT ID: NCT03841721 Active, not recruiting - Healthy Clinical Trials

Linezolid in Healthy Volunteers

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy. The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.