Clinical trials: Fed
Bioequivalence
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in…
- Trial name
- NCT06987773
- Testing
- RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Pain
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants.
- Trial name
- NCT05737069
- Testing
- Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen)
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- HALEON
Prostate Neoplasms, Prostate Cancer
A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic…
- Trial name
- NCT01424930
- Testing
- Abiraterone, Prednisone
- Where
- 2 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Janssen-Ortho Inc., Canada
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Healthy
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
- Trial name
- NCT01101178
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy Participants
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy…
- Trial name
- NCT04916769
- Testing
- Bosutinib capsule
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer, Pharmacokinetics After Oral Intake
A Comparison of the Pharmacokinetic Properties of ARN-75039 Tablets With Excipients to Neat ARN-75039 in Hydroxypropyl Methylcellulose (HPMC) Capsules in Healthy Adult Participants Under Fed Conditions
ARN-75039-103 is a comparative, randomized, single-dose, cross-over study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules compared with ARN-75039 with excipients in…
- Trial name
- NCT06911242
- Testing
- ARN-75039
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arisan Therapeutics, Inc.
Parkinson
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.
- Trial name
- NCT02071823
- Testing
- BIA 9-1067
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.
- Trial name
- NCT06075277
- Testing
- zongertinib
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Food-Effect Study in Healthy Participants
This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of lasmiditan in healthy participants.
- Trial name
- NCT02233296
- Testing
- Lasmiditan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Pulmonary Disease, Chronic Obstructive
Study of Danirixin in Japanese Healthy Elderly Male Subjects
Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT03136380
- Testing
- GSK1325756H
- Where
- 2 sites in Japan
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
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
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1)…
- Trial name
- NCT03892616
- Testing
- BI 1358894 (B), BI 1358894 (C), BI 1358894 (D)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Colchicine Tablets
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with…
- Trial name
- NCT01021020
- Testing
- Colchicine, Colchicine/Probenecid
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Anemia, Iron Deficiency
Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.
- Trial name
- NCT04626414
- Testing
- Ferric maltol capsule, Ferric maltol suspension
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shield Therapeutics
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.
- Trial name
- NCT01100320
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP