Clinical trials: Healthy Subjects in Fasted and Fed State
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and PK profile of single and repeat ascending doses of GSK3186899 in healthy subjects.
- Trial name
- NCT03874234
- Testing
- GSK3186899
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of…
- Trial name
- NCT01154218
- Testing
- crizotinib
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to…
- Trial name
- NCT00897390
- Testing
- Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infections, Bacterial
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG])…
- Trial name
- NCT02853435
- Testing
- Gepotidacin RC Tablet, Gepotidacin HSWG Tablet, Gepotidacin Capsule
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets…
- Trial name
- NCT01365091
- Testing
- Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR)
- Where
- Brazil
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI…
- Trial name
- NCT05155306
- Testing
- BI 1358894, intended Commercial Formulation (iCF) (T), BI 1358894, Trial Formulation 2 (TFII) (R)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin…
- Trial name
- NCT04684420
- Testing
- Glucophage® XR RM Test, Glucophage® XR Reference
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Inflammatory Bowel Diseases
GSK2983559 First Time in Human Study
This study is the first administration of GSK2983559, a selective receptor interacting protein 2 (RIP2) kinase inhibitor, to humans. This will be randomized, double-blinded (sponsor open) and two part study (A and B).
- Trial name
- NCT03358407
- Testing
- GSK2983559
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations.
- Trial name
- NCT03457727
- Testing
- Danirixin, Omeprazole
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis)…
- Trial name
- NCT01068717
- Testing
- Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state), Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants
This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose.
- Trial name
- NCT04504435
- Testing
- GSK3494245
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer Study
Ibuprofen Suspension Bioequivalence Study
The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.
- Trial name
- NCT02503085
- Testing
- Nurofen for Children®, Algifor Dolo Junior®
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
Autoimmune Diseases
A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses
GSK2982772 is a first-in-class, highly selective, receptor-interacting protein-1 (RIP1) kinase inhibitor being developed for the treatment of inflammatory bowel disease, plaque psoriasis (PsO), rheumatoid arthritis (RA) and other…
- Trial name
- NCT03266172
- Testing
- GSK2982772 Modified Release, GSK2982772 Immediate Release
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Glucophage Immediate Release (GIR) China Bioequivalence Study
The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
- Trial name
- NCT03393208
- Testing
- Test GIR, Reference GIR
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioavailability
Bioavailability of Belumosudil (KD025) in Healthy Male Subjects
Phase 1 bioavailability study to evaluate the pharmacokinetics (PK) and tolerability/safety of the belumosudil tablet formulation in the fasted and fed states and compared to the belumosudil capsule formulation in the fed state.
- Trial name
- NCT02557139
- Testing
- Belumosudil Tablet, Belumosudil Capsule
- Where
- United Kingdom
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Kadmon Corporation, LLC