Clinical trials: Biological Availability
Diabetes Mellitus: Type 1
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge.
- Trial name
- NCT00662857
- Testing
- Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder, RAA Population
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Mannkind Corporation
Healthy Volunteers
Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants
The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of…
- Trial name
- NCT03131895
- Testing
- 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Takeda
Oncology
A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291
The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall cell lung cancer. Lung cancer has been the most common cancer in the world for several decades and represents 12.8% of all new cancer…
- Trial name
- NCT02491944
- Testing
- AZD9291, [14C]AZD9291
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Tumor
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.
- Trial name
- NCT04472650
- Testing
- Sitravatinib
- Where
- Australia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy
Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
- Trial name
- NCT02163421
- Testing
- Vedolizumab SC, Vedolizumab IV
- Where
- 2 sites in United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Infections, Papillomavirus
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is…
- Trial name
- NCT00652938
- Testing
- HPV Vaccine (GSK580299) Cervarix TM, Engerix B
- Where
- 7 sites in Netherlands, Sweden
- Volunteers
- 744 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Diabetes Mellitus
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin.
- Trial name
- NCT01374178
- Testing
- LY2963016, Lantus
- Where
- Singapore
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible Tablet praziquantel (ODT-PQZ) (MSC1028703A)…
- Trial name
- NCT02325713
- Testing
- Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide, ODT-PZQ
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00684723
- Testing
- Lovastatin 40 mg Tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
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.
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate…
- Trial name
- NCT04128293
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral…
- Trial name
- NCT03811834
- Testing
- Mobocertinib
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Normal Healthy Volunteers
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution
The purpose of this open-label, single-dose, randomized, three-treatment, three-period, four-sequence, crossover study is to evaluate the relative bioavailability of a test formulation of lofexidine granules for reconstitution…
- Trial name
- NCT04188730
- Testing
- Lofexidine (granules for reconstitution), LUCEMYRA (lofexidine) tablets
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Acne Vulgaris
A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.
- Trial name
- NCT03599193
- Testing
- Tazarotene Lotion, 0.1%, Tazarotene Cream, 0.1%
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Parkinson Disease
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.
- Trial name
- NCT02305316
- Testing
- BIA 9-1067 non-micronized, BIA 9-1067 micronized
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy Subjects
Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.
- Trial name
- NCT04072146
- Testing
- Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg, OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Oyster Point Pharma, Inc.
Healthy Adult Subjects
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects
- Trial name
- NCT04776135
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy
Ursodiol Tablets 500 mg Under Fasting Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
- Trial name
- NCT00909610
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA