Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers
NCT02171442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2014-06-24
Summary
The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS and BIBR 953 ZW in man.
Conditions
- Healthy
Interventions
- DRUG
-
BIBR 953 ZW Intravenously
5 mg, 2.8 MBq (76 µCi)
- DRUG
-
BIBR 1048 Oral Solution
200 mg free base, 2.8 MBq (76 µCi)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-04-30
- Primary Completion
- 2002-05-31
More Related Trials
-
Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects
NCT02170896 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
NCT02170740 ·Status: COMPLETED ·Phase: PHASE1
-
BIBR 953 ZW in Healthy Elderly Subjects
NCT02173730 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BIBR 953 ZW After BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as Hydroxypropyl Methylcellulose (HPMC) Polymorph II Capsule Relative to HPMC Polymorph I Capsule in Healthy Subjects.
NCT02170974 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food
NCT02170922 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
NCT02183610 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers
NCT02170831 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
NCT02170792 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BIIL 284 BS in Healthy Volunteers
NCT02266550 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin
NCT02170909 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
NCT02182154 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin
NCT02170844 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How BI 1819479 is Taken up and Processed by the Body
NCT07065617 ·Status: TERMINATED ·Phase: PHASE1
-
Bioavailability of BIBR 953 ZW in Healthy Subjects
NCT02170766 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body
NCT06166992 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects
NCT02171000 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects
NCT02184338 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
NCT02071121 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
NCT02259894 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
NCT05515328 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
BI 10773 Administered as Oral Solution to Healthy Male Volunteers
NCT02172274 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers
NCT02183532 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers
NCT02203487 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers
NCT02214914 ·Status: COMPLETED ·Phase: PHASE1